Pharmaceutical

Findings Presented at 48 th Annual European Society for Blood and Marrow Transplantation Meeting

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today the presentation of findings from a systematic literature review and meta-analysis of data from real-world observational studies of PREVYMIS™ (letermovir) for primary prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in patients undergoing allogeneic hematopoietic cell transplantation (alloHCT) who were CMV-seropositive. In the analysis of 48 real-world observational studies, compared to controls (mostly preemptive therapy), primary prophylaxis with PREVYMIS was associated at 100 days of follow-up after alloHCT with: 87% lower odds of CMV reactivation (N=3,054 across 18 studies; Pooled Odds Ratio (POR)=0.13, [95% CI, 0.08, 0.22]); 91% lower odds for clinically significant CMV infection (N=3,993 across 21 studies; POR=0.09, [95% CI, 0.05, 0.14]); 69% lower odds of CMV disease (N=1,838 across 10 studies; POR=0.31, [95% CI, 0.12, 0.77]); 94% lower odds of CMV-related hospitalization (N=905 across 2 studies; POR=0.06, [95% CI, 0.01, 0.28]); and 48% lower odds of Grade 2 or greater graft versus host disease (GvHD) (N=471 across 6 studies; POR=0.52, [95% CI, 0.32, 0.86]). Consistent results were observed at 200 days of follow-up with respect to CMV reactivation, clinically significant CMV infection, and CMV disease. See additional results below. The findings were presented during an oral session at the European Society for Blood and Marrow Transplantation (EBMT) 48 th Annual Meeting (Abstract #OS04-07).

Patients undergoing alloHCT who are CMV-seropositive [R+] are at high risk for CMV reactivation. CMV infection is a common clinically significant complication in these patients and early CMV reactivation after alloHCT is associated with increased mortality. PREVYMIS is a first-in-class antiviral agent that was approved by the U.S. Food and Drug Administration in 2017 and is indicated for prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT).

"CMV reactivation in patients who undergo alloHCT can lead to potentially serious health complications," said Dr. Roy Chemaly, director, Clinical Virology Research Program at the University of Texas MD Anderson Cancer Center. "This analysis of real-world effectiveness of letermovir builds upon the evidence from the Phase 3 clinical trial in which letermovir as prophylaxis reduced the risk of CMV infection in CMV-seropositive patients. This new analysis also provides data on the potential of letermovir to reduce the odds of CMV-related hospitalization and graft versus host disease."

"In 2017, PREVYMIS was the first new medicine approved in the U.S. in over a decade for prophylaxis of CMV infection in adults who are CMV-seropositive and receive allogeneic hematopoietic cell transplantation," said Sanjay Merchant, executive director, Center for Observational and Real-world Evidence, Merck Research Laboratories. "We are encouraged that the findings from this comprehensive literature review and meta-analysis of real-world observational studies reinforce the effectiveness of PREVYMIS in these patients at risk for CMV infection and disease."

Real-World Outcomes for Primary Prophylaxis of CMV Infection and Disease Using PREVYMIS

The objective of the analysis was to assess the effectiveness of primary prophylaxis with PREVYMIS among adults undergoing alloHCT using systematic literature review and meta-analysis of data from real-world observational studies. An initial search of peer-reviewed publications via PubMed and Embase and relevant conference proceedings through October 2021 identified 576 records. Further screening to identify publications that met the pre-specified inclusion criteria yielded 48 distinct studies (22 full publications and 26 conference proceedings) that reported on outcomes of PREVYMIS for primary prophylaxis in patients undergoing alloHCT. These studies involved patients predominantly in the United States, Italy, and Japan and employed a range of timepoints for initiation of PREVYMIS post-transplant (0 - 42 days) and duration of therapy (79 - 191 days). Forty of the 48 studies were comparator studies and, in all but one study, the control was preemptive therapy; the other eight studies were single-arm studies.

Outcomes measured included CMV reactivation, clinically significant CMV infection, CMV disease, CMV-related hospitalizations, time to CMV viremia (infection detected in the blood), graft versus host disease (GvHD) (Grade 2 or greater), and all-cause and non-relapse mortality. In addition to the results discussed above, primary prophylaxis with PREVYMIS was also associated in this meta-analysis with the following outcomes compared to controls:

  • At 100 days of follow-up after alloHCT:
    • 30% lower odds of all-cause mortality (N=1,723 across 5 studies; POR=0.70, [95% CI, 0.46, 1.07])
    • 30% lower odds of non-relapse mortality (N=889 across 3 studies; POR=0.70, [95% CI, 0.39, 1.25])
  • At 200 days of follow-up after alloHCT:
    • 76% lower odds of CMV reactivation (N=1,297 across 5 studies; POR=0.24, [95% CI, 0.18, 0.32])
    • 81% lower odds for clinically significant CMV infection (N=2,771 across
      14 studies; POR=0.19, [95% CI, 0.14, 0.25])
    • 65% lower odds of CMV disease (N=1,261 across 7 studies; POR=0.35,
      [95% CI, 0.16, 0.78])
  • At more than 200 days of follow-up after alloHCT:
    • 78% lower odds of CMV reactivation (N=2,109 across 8 studies; POR=0.22, [95% CI, 0.15, 0.32])
    • 27% lower odds for all-cause mortality (N=2,685 across 15 studies; POR=0.73, [95% CI, 0.60, 0.90])
    • 35% lower odds for non-relapse mortality (N=1,829 across 6 studies; POR=0.65, [95% CI, 0.47, 0.90])

Selected Safety Information about PREVYMIS (letermovir)

PREVYMIS is contraindicated in patients receiving pimozide or ergot alkaloids. Increased pimozide concentrations may lead to QT prolongation and torsades de pointes. Increased ergot alkaloids concentrations may lead to ergotism. PREVYMIS is contraindicated with pitavastatin and simvastatin when co-administered with cyclosporine. Significantly increased pitavastatin or simvastatin concentrations may lead to myopathy or rhabdomyolysis.

The concomitant use of PREVYMIS and certain drugs may result in potentially significant drug interactions, some of which may lead to adverse reactions (PREVYMIS or concomitant drugs) or reduced therapeutic effect of PREVYMIS or the concomitant drug. Consider the potential for drug interactions prior to and during PREVYMIS therapy; review concomitant medications during PREVYMIS therapy; and monitor for adverse reactions associated with PREVYMIS and concomitant medications.

The cardiac adverse event rate (regardless of investigator-assessed causality) was higher in subjects receiving PREVYMIS than placebo (13% vs 6%). The most common cardiac adverse events were tachycardia (reported in 4% PREVYMIS subjects and 2% placebo subjects) and atrial fibrillation (reported in 3% PREVYMIS subjects and 1% placebo subjects). Among those subjects who experienced one or more cardiac adverse events, 85% of PREVYMIS and 92% of placebo subjects had events reported as mild or moderate in severity.

The rate of adverse events occurring in at least 10% of PREVYMIS-treated HSCT recipients and at a frequency at least 2% greater than placebo were nausea (27% vs 23%), diarrhea (26% vs 24%), vomiting (19% vs 14%), peripheral edema (14% vs 9%), cough (14% vs 10%), headache (14% vs 9%), fatigue (13% vs 11%), and abdominal pain (12% vs 9%).

The most frequently reported adverse event that led to study drug discontinuation was nausea (occurring in 2% of PREVYMIS subjects and 1% of placebo subjects). Hypersensitivity reaction, with associated moderate dyspnea, occurred in one subject following the first infusion of IV PREVYMIS after switching from oral PREVYMIS, leading to treatment discontinuation.

Co-administration of PREVYMIS with drugs that are inhibitors of organic anion-transporting polypeptide 1B1/3 (OATP1B1/3) transporters may result in increases in letermovir plasma concentrations.

Co-administration of PREVYMIS with inducers of transporters (e.g. P-gp) and/or enzymes (e.g. UGTs) is not recommended due to the potential for a decrease in letermovir plasma concentrations.

Co-administration of PREVYMIS with midazolam results in increased midazolam plasma concentrations. Co-administration of PREVYMIS with drugs that are CYP3A substrates may result in clinically relevant increases in the plasma concentrations of co-administered CYP3A substrates.

Co-administration of PREVYMIS with drugs that are substrates of OATP1B1/3 transporters may result in a clinically relevant increase in plasma concentrations of co-administered OATP1B1/3 substrates.

The magnitude of CYP3A- and OATP1B1/3-mediated drug interactions on co-administered drugs may be different when PREVYMIS is co-administered with cyclosporine. See the prescribing information for cyclosporine for information on drug interactions with cyclosporine.

If dose adjustments of concomitant medications are made due to treatment with PREVYMIS, doses should be readjusted after PREVYMIS treatment is completed.

Drug interactions may occur based on results from studies. Drug interactions may also occur based on predicted interactions. Potentially significant drug interactions include, but are not limited to, the following (information below applies to co-administration of PREVYMIS and the concomitant drug without cyclosporine, unless otherwise indicated):

  • Anti-arrhythmic Agents
    • Amiodarone: increases amiodarone concentration
  • Antibiotics
    • Nafcillin: decreases letermovir concentration
  • Anticoagulants
    • Warfarin: decreases warfarin concentration
  • Anticonvulsants
    • Carbamazepine: decreases letermovir concentration
    • Phenobarbital: decreases letermovir concentration
    • Phenytoin: decreases both phenytoin and letermovir concentrations
  • Antidiabetic Agents
    • Glyburide: increases glyburide concentration
    • Repaglinide: increases repaglinide concentration
    • Rosiglitazone: increases rosiglitazone concentration
  • Antifungals
    • Voriconazole: decreases voriconazole concentration
  • Antimycobacterials
    • Rifabutin: decreases letermovir concentration
    • Rifampin: decreases letermovir concentration
  • Antipsychotics
    • Pimozide: increases pimozide concentration; co-administration is contraindicated
    • Thioridazine: decreases letermovir concentration
  • Endothelin Antagonists
    • Bosentan: decreases letermovir concentration
  • Ergot Alkaloids
    • Ergotamine: increases ergotamine concentration; co-administration is contraindicated
    • Dihydroergotamine: increases dihydroergotamine concentration; co-administration is contraindicated
  • Herbal Products
    • St. John's wort (Hypericum perforatum) : decreases letermovir concentration
  • HIV Medications
    • Efavirenz: decreases letermovir concentration
    • Etravirine: decreases letermovir concentration
    • Nevirapine: decreases letermovir concentration
  • HMG-CoA Reductase Inhibitors
    • Pitavastatin, simvastatin: increases HMG-CoA reductase inhibitors concentration; co-administration is contraindicated when PREVYMIS is co-administered with cyclosporine
    • Atorvastatin: increases atorvastatin concentration
    • Fluvastatin, lovastatin, pravastatin, rosuvastatin: increases HMG-CoA reductase inhibitors concentration
  • Immunosuppressants
    • Cyclosporine: increases both cyclosporine and letermovir concentrations
    • Sirolimus: increases sirolimus concentration
    • Tacrolimus: increases tacrolimus concentration
  • Proton Pump Inhibitors
    • Omeprazole: decreases omeprazole concentration
    • Pantoprazole: decreases pantoprazole concentration
  • Wakefulness-Promoting Agents
    • Modafinil: decreases letermovir concentration
  • CYP3A Substrate Examples
    • Alfentanil, fentanyl, midazolam and quinidine: may increase CYP3A substrate concentration
    • Pimozide and ergot alkaloids are contraindicated

The safety and efficacy of PREVYMIS in patients below 18 years of age have not been established.

For patients with creatinine clearance (CLcr) greater than 10 mL/min (by Cockcroft-Gault equation), no dosage adjustment of PREVYMIS is required based on renal impairment. The safety of PREVYMIS in patients with end-stage renal disease (CLcr less than 10 mL/min), including patients on dialysis, is unknown.

No dosage adjustment of PREVYMIS is required based on mild (Child-Pugh Class A) to moderate (Child-Pugh Class B) hepatic impairment. PREVYMIS is not recommended for patients with severe (Child-Pugh Class C) hepatic impairment.

About PREVYMIS (letermovir)

PREVYMIS is the only drug approved in the United States for prophylaxis of CMV infection and disease in adults who are CMV-seropositive and have received an allogeneic HSCT. PREVYMIS is also approved in more than 50 countries outside of the United States, including EU member states, Canada, Japan and China. PREVYMIS is a first-in-class non-nucleoside CMV inhibitor (3,4 dihydro-quinazolines) and inhibits viral replication by specifically targeting the viral terminase complex. Cross resistance is not likely with drugs outside of this class. PREVYMIS is fully active against viral populations with substitutions conferring resistance to CMV DNA polymerase inhibitors. These DNA polymerase inhibitors are fully active against viral populations with substitutions conferring resistance to PREVYMIS. PREVYMIS has no activity against other viruses.

Under an agreement signed in 2012, Merck (through a subsidiary) purchased worldwide rights to develop and commercialize letermovir from AiCuris GmbH & Co KG ( www.aicuris.com ).

About CMV and Treatment

CMV is a common virus that infects people of all ages. Many adults in the United States are CMV seropositive, meaning they have CMV antibodies in their blood, indicating a previous exposure to or primary infection with CMV. People with normal immune systems rarely develop CMV symptoms after initial infection, with the virus typically remaining inactive or latent in the body for life. A weakened immune system may give the virus a chance to reactivate, potentially leading to symptomatic disease or a secondary infection due to other pathogens. CMV disease can lead to end-organ damage, including gastrointestinal tract disease, pneumonia or retinitis. Transplant recipients who develop CMV infection post-transplant are at increased risk for transplant failure and death. CMV prophylaxis with certain existing antivirals has been associated with drug-specific effects, including myelosuppression and renal toxicity, in HSCT recipients.

About Merck

For over 130 years, Merck, known as MSD outside the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals – including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases – as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com and connect with us on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA

This news release of Merck & Co., Inc., Kenilworth, N.J., USA (the "company") includes "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.

Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the global outbreak of novel coronavirus disease (COVID-19); the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.

The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company's Annual Report on Form 10-K for the year ended December 31, 2021 and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site ( www.sec.gov ).

Please see Prescribing Information for PREVYMIS (letermovir) at: https://www.merck.com/product/usa/pi_circulars/p/prevymis/prevymis_pi.pdf and Patient Information/Medication Guide for PREVYMIS (letermovir) at: https://www.merck.com/product/usa/pi_circulars/p/prevymis/prevymis_ppi.pdf

Media :

Melissa Moody
(215) 407-3536

Deb Wambold
(215) 779-2234

Investors:

Peter Dannenbaum
(908) 740-1037

Steven Graziano
(908) 740-6582

News Provided by Business Wire via QuoteMedia

MRK
OTC:BCTXF

BriaCell Announces Grant to Investigator Dr. Saveri Bhattacharya at Sidney Kimmel Cancer Center – Jefferson Health

Highlights:

  • Grant awarded to Dr. Saveri Bhattacharya, Principal Investigator of the Phase I/IIa combination study of Bria-IMT™ with KEYTRUDA® (by Merck) in advanced breast cancer at Thomas Jefferson University.
  • Merck to provide KEYTRUDA® for use in the combination study.
  • The Investigator Grant validates and will build on the encouraging preliminary data from BriaCell’s combination study of Bria-IMT™ with KEYTRUDA® (Link).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, today announced that Dr. Saveri Bhattacharya, a board-certified medical oncologist and recognized expert in breast cancer treatment at the Sidney Kimmel Cancer Center – Jefferson Health in Philadelphia, PA, has been selected to receive support from the Merck Investigator Studies Program (“MISP”). The Investigator Grant is a highly coveted award granted by Merck & Co., Inc. (“Merck”) (NYSE: MRK) to leading investigators with highly innovative clinical studies.

Keep reading...Show less

Merck Announces Q4 and Full-Year 2019 Financial Results

Merck (NYSE:MRK) reported quarterly worldwide sales at US$11.9 billion in Q4 in its financial results for the fourth quarter of 2019 and its full fiscal 2019 year.

As quoted in the press release:

Keep reading...Show less
OTC:BCTXF

BriaCell’s Clinical Data Accepted to be Presented at the Annual Symposium of Society of Surgical Oncology 2020 in Boston

Safety and early efficacy data to be presented from clinical trial of Bria-IMT™ in combination with immune checkpoint inhibitors in advanced breast cancer:

  • Bria-IMT™ in combination with pembrolizumab (KEYTRUDA®; by Merck & Co., Inc.);
  • Bria-IMT™ in combination with INCMGA00012 (by Incyte Corporation).

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, is pleased to announce that the data of its clinical studies with its lead product candidate, Bria-IMT™, will be presented the at the Annual Symposium of Society of Surgical Oncology (SSO) 2020 – International Conference on Surgical Cancer Care taking place March 25-28 in Boston, MA.

Keep reading...Show less
OTC:BCTXF

BriaCell Invited to Present at Mount Sinai’s Frontiers in Academic Pathology Symposium at The New York Academy of Medicine

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapies for advanced breast cancer, announced today that it will present at the “Frontiers in Academic Pathology” symposium, hosted by the Icahn School of Medicine at Mount Sinai, to be held on Friday, January 31, 2020 at The New York Academy of Medicine, 1216 Fifth Avenue in New York. The symposium focus will include molecular biomarkers, experimental diagnostics and liquid biopsies, all of which factor heavily in the development of BriaCell’s companion diagnostics under development, including BriaCell’s HLA-matching hypothesis and recently-announced Grade I/II biomarkers.

Dr. Bill Williams, BriaCell’s President & CEO, will be presenting BriaCell’s unique and effective immunotherapy approach at the conference, focusing on the biomarkers noted to date in determining clinical benefit in advanced stage breast cancer.

Keep reading...Show less
BriaCell Provides Update on Remarkable Responder

BriaCell Provides Update on Remarkable Responder

Highlights:

  • Patient initially identified September 19, 2019 as a Remarkable Responder;
  • Patient has continued to experience a highly remarkable reduction in tumors that had metastasized to areas outside of the breasts;
  • A metastasized tumor behind the left eye orbital region, which had pushed the eye forward from the skull, has now completely disappeared;
  • Prior to BriaCell’s treatment, patient had failed prior regimens with 16 agents (13 chemotherapy and 3 hormonal);
  • Patient remains on BriaCell’s treatment.

BriaCell Therapeutics Corp. (“BriaCell” or the “Company”) (TSXV:BCT, OTCQB:BCTXD), a clinical-stage biotechnology company specializing in targeted immunotherapy for advanced breast cancer, is pleased to provide an update on the previously-announced (Link) top responder (“Remarkable Responder”) in the combination study of its lead candidate, Bria-IMT™, with Incyte’s INCMGA00012, a PD-1 inhibitor.

Keep reading...Show less

Pfizer Announces Positive Top-Line Results from Phase 3 Study of 20-Valent Pneumococcal Conjugate Vaccine in Infants

  • Pivotal top-line data demonstrate a four-dose series of 20-valent pneumococcal conjugate vaccine candidate (20vPnC), if approved, would provide the broadest serotype coverage of any pneumococcal conjugate vaccine in infants
  • 20vPnC elicited robust immune responses to all 20 serotypes meeting the statistical non-inferiority criteria for the co-primary objective after Dose 4
  • 20vPnC demonstrated a favorable safety and tolerability profile similar to Prevnar 13 ®
  • Pfizer plans to submit an sBLA by the end of this year, subject to discussions with U.S. FDA

Pfizer Inc. (NYSE:PFE) today announced positive top-line results from its pivotal U.S. Phase 3 study (NCT04382326) in infants evaluating its 20-valent pneumococcal conjugate vaccine candidate (20vPnC) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcus) serotypes contained in the vaccine for the pediatric population.

The study had two co-primary objectives, associated with immunogenicity responses one month after the third and fourth doses of the four-dose vaccination series, respectively: non-inferiority (NI) of the percentage of participants with predefined serotype-specific immunoglobin G (IgG) concentrations after Dose 3 and NI of IgG geometric mean concentrations (GMCs) after Dose 4. All 20 serotypes met the co-primary objective of NI of IgG GMCs after Dose 4. Fourteen of the 20 serotypes met the co-primary objective of NI of the percentage of participants with predefined IgG levels after Dose 3 (two serotypes missed by a wider margin while four narrowly missed), and all serotypes met noninferiority for the key secondary objective of IgG GMCs after Dose 3. All 20 serotypes elicited robust functional responses (OPA) and increases in antibody responses after Dose 4, with the totality of data supporting the potential benefit of all serotypes in this 20-valent vaccine candidate.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

BRODSKY & SMITH SHAREHOLDER UPDATE: Notifying Investors of the Following Investigations:) Professional Holding Corp. , Global Blood Therapeutics, Inc. , CyberOptics Corporation , EVO Payments, Inc.    

Brodsky & Smith reminds investors of the following investigations. If you own shares and wish to discuss the investigation, contact Jason Brodsky ( jbrodsky@brodskysmith.com ) or Marc Ackerman ( mackerman@brodskysmith.com ) at 855-576-4847. There is no cost or financial obligation to you.

Professional Holding Corp. (Nasdaq – PFHD)

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Pfizer and Valneva Initiate Phase 3 Study of Lyme Disease Vaccine Candidate VLA15

  • Approximately 6,000 participants 5 years of age and older will be enrolled in Lyme disease-endemic regions in Europe and the U.S.

Pfizer Inc. (NYSE: PFE) and Valneva SE (Nasdaq: VALN; Euronext Paris: VLA) today announced the initiation of a Phase 3 clinical study, Vaccine Against Lyme for Outdoor Recreationists (VALOR) (NCT05477524), to investigate the efficacy, safety and immunogenicity of their investigational Lyme disease vaccine candidate, VLA15.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220808005463/en/

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Pfizer to Acquire Global Blood Therapeutics for $5.4 Billion to Enhance Presence in Rare Hematology

Proposed acquisition drives growth by bringing leading sickle cell disease expertise, portfolio and pipeline to Pfizer with potential combined worldwide peak sales of more than $3 billion

Potential to address the full spectrum of critical needs in the underserved sickle cell community

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Myovant Sciences and Pfizer Receive U.S. FDA Approval of MYFEMBREE®, a Once-Daily Treatment for the Management of Moderate to Severe Pain Associated With Endometriosis

  • Data from the Phase 3 SPIRIT program showed MYFEMBREE reduced menstrual pain and non-menstrual pelvic pain in premenopausal women with endometriosis, and a loss of mean bone mineral density of less than 1% from baseline through one year of treatment
  • Myovant and Pfizer will continue to jointly commercialize MYFEMBREE, with product available immediately
  • Myovant to host conference call and webcast on Monday, August 8, 2022, at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time

Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE ® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) as a one-pill, once-a-day therapy for the management of moderate to severe pain associated with endometriosis in pre-menopausal women, with a treatment duration of up to 24 months. The approval is supported by one-year efficacy and safety data, including 24-week data from the Phase 3 SPIRIT 1 and SPIRIT 2 trials, which were published in The Lancet and the first 28 weeks of an open-label extension study for eligible women who completed either SPIRIT 1 or SPIRIT 2. MYFEMBREE also is approved for heavy menstrual bleeding associated with uterine fibroids in pre-menopausal women. Myovant and Pfizer will continue to jointly commercialize MYFEMBREE in the U.S. and product is available immediately.

"Endometriosis is a painful, chronic disease with limited therapies to manage symptoms," said Juan Camilo Arjona Ferreira, M.D., Chief Medical Officer of Myovant Sciences, Inc. "The new MYFEMBREE indication helps advance our mission to redefine care for women by helping address a disease with high unmet need, giving women and physicians a new meaningful treatment option to manage moderate to severe pain associated with endometriosis."

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Jamieson Wellness Inc. Reports Second Quarter 2022 Financial Results

Company Increases Fiscal 2022 Guidance and Raises Second Quarter Dividend

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today reported financial results for its second quarter ended June 30, 2022. All amounts are expressed in Canadian dollars. Certain metrics, including those expressed on an adjusted basis, are non-IFRS and other financial measures. See "Non-IFRS and Other Financial Measures" below.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×