CHMP Adopts Positive Opinion Recommending Hepcludex®  for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

CHMP Adopts Positive Opinion Recommending Hepcludex® for Full Marketing Authorization for the Treatment of Hepatitis Delta Virus

--   If Granted by the European Commission, Hepcludex will Become the Only Approved Treatment for HDV in the EU --

Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Hepcludex ® (bulevirtide) for the treatment of adults with chronic HDV and compensated liver disease, and recommended granting full Marketing Authorisation (MA) that is no longer subject to specific obligations. Bulevirtide was initially granted conditional marketing authorisation in July 2020 to provide people living with HDV urgent access to treatment. The CHMP recommendation for full Marketing Authorisation of bulevirtide follows the submission of the Phase 3 MYR301 Week 48 study data, which reinforces the efficacy and safety profile of bulevirtide for the treatment of HDV.

HDV is the most severe form of viral hepatitis and affects an estimated 5% of people living with hepatitis B (HBV), with a global prevalence of over 12 million people worldwide. For people living with HDV with advanced disease progression, including cirrhosis, mortality rates can be as high as 50% within five years, presenting significant disease burden and high healthcare-related costs.

"People living with HDV have had very limited treatment options and without treatment, they often rapidly progress to severe liver disease or liver cancer. Until bulevirtide, we have not had any approved options to treat these patients, but we now have a treatment conditionally approved specifically for HDV with a positive recommendation for full approval," said Heiner Wedemeyer, MD, Director, Clinic for Gastroenterology, Hepatology and Endocrinology at Hannover Medical School. "It gives clinicians additional confidence on the efficacy and safety with longer-term use."

"The MYR301 Week 48 data supporting this recommendation for full approval demonstrates that with longer treatment with bulevirtide, higher response rates are achieved, meaning this rare, life-threatening disease can be better managed," said Frank Duff, MD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. "As a company that is a leader in liver disease and virology, we have been committed to improving the lives of people living with viral hepatitis for more than two decades. This marks a significant step forward as it offers real hope to people living with HDV, who have previously faced an uncertain future."

The positive opinion from the CHMP is based on the review of the pivotal Phase 3 MYR301 Week 48 study data demonstrating the efficacy and safety of bulevirtide, resulting in the removal of the specific obligation related to the conditional marketing authorization. The European Commission (EC) will review the CHMP recommendation, and if adopted, bulevirtide will be fully authorized in the European Union for the treatment of adults with chronic HDV and compensated liver disease.

Gilead is working with several regulatory authorities on marketing applications for bulevirtide in other parts of the world. In the U.S. bulevirtide was granted Breakthrough Therapy and Orphan Drug designations by the Food and Drug Administration (FDA). While bulevirtide is currently not approved in the U.S., Gilead remains in active discussions with the FDA, with the aim of bringing bulevirtide to people living with HDV in the U.S. as soon as possible.

About HDV
Chronic HDV is the most severe form of viral hepatitis and can have mortality rates as high as 50% within five years in cirrhotic patients. HDV occurs only as a co-infection in individuals who have HBV. It is estimated that at least 12 million people worldwide are currently co-infected with HDV and HBV. HDV co-infection is associated with a faster progression to liver fibrosis, cirrhosis and hepatic decompensation and an increased risk of liver cancer and death. In the U.S. and Europe, it is estimated that there are more than 230,000 people living with HDV; however, it remains widely underdiagnosed around the world.

About Gilead Sciences in Liver Disease
For more than 20 years, Gilead has sought to address some of the biggest challenges in liver disease. The company has transformed the trajectory of multiple liver diseases through a relentless pursuit of innovation and pioneering access programs to bring meaningful therapies to people around the world. More work is required, and Gilead is committed to advancing innovative therapeutics to address the most pressing unmet needs in liver disease and overcoming barriers to better care.

About Gilead Sciences
Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials or studies, including those involving Hepcludex; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the European Commission may not grant full Marketing Authorization of Hepcludex for the treatment of adults with chronic HDV and compensated liver disease, and the FDA and other regulatory authorities may not approve bulevirtide for the treatment of HDV, and the risk that any such approvals, if granted, may be subject to significant limitations on use; and any assumptions underlying any of the foregoing. These and other risks, uncertainties and factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.

Hepcludex, Gilead and the Gilead logo are registered trademarks of Gilead Sciences, Inc., or its related companies.

For more information about Gilead, please visit the company's website at www.gilead.com , follow Gilead on Twitter (@Gilead Sciences) or call Gilead Public Affairs at 1-800-GILEAD-5 or 1-650-574-3000.

Jacquie Ross, Investors
investor_relations@gilead.com

Meaghan Smith, Media
public_affairs@gilead.com

News Provided by Business Wire via QuoteMedia

GILD
The Conversation (0)
Sort by
Gilead Sciences Announces First Quarter 2023 Financial Results

Gilead Sciences Announces First Quarter 2023 Financial Results

Product Sales Excluding Veklury Increased 15% Year-Over-Year to $5.7 billion

Biktarvy Sales Increased 24% Year-Over-Year to $2.7 billion

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
abigail echo-hawk

CORRECTION: Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

This document corrects and updates the final paragraph in the body of this news release. No other changes were required in this release.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
"investingnews.com"

Contakt World Becomes Data Partner for Health Equity Tracker Project to Improve the Collection of De-Identified Racial & Ethnic Minority Data Using Smart Health RM, Engagency, and Future Services

Enables Contakt World mission to improve health equity and reduce disparities in the fight against Covid-19 and all diseases via award-winning SaaS platform

  • Covid-19 has proven to be the "great revealer" of disparities in healthcare

  • Contakt World (CSE: HELP) and Satcher Health Leadership Institute, Morehouse School of Medicine executed a strategic collaboration in October 2020
  • Health Equity Tracker, supported by Google.org, Gilead Sciences (Nasdaq: GILD), Annie E. Casey Foundation, and CDC Foundation, is now operational
  • Contakt World's SaaS Platform, Smart Health RM, will help drive de-identified data to Health Equity Tracker to improve health equity and reduce disparities of care

Contakt World Technologies Corp. (CSE: HELP) (OTC: TLOOF) (FSE: B2I0) (the "Company" or "Contakt World") today announced its agreement in principle with Satcher Health Leadership Institute, Morehouse School of Medicine ("SHLI") to help collect de-identified demographic data for the Health Equity Tracker Project through Smart Health RM and other products and services provided by Contakt World like Engagency. This updates the previously announced collaboration between Contakt World and SHLI now that Health Equity Tracker is operational.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

HOOKIPA Advances HIV and HBV Vaccine Research with Gilead

HOOKIPA Pharma (NASDAQ:HOOK) announced that it has made progress in its collaboration with Gilead Sciences (NASDAQ:GILD) for arenavirus-based therapeutics intended to support cures for chronic Hepatitis B virus (HBV) and human immunodeficiency virus (HIV) infections.

As quoted in the press release:

Keep reading...Show less

Adicet Bio Reports Inducement Grants Under Nasdaq Listing Rule 5635

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced it granted inducement awards on March 31, 2025.

Two individuals were hired by Adicet in March 2025. In the aggregate, Adicet granted new hires non-qualified stock options to purchase 38,600 shares of Adicet's common stock with an exercise price of $0.76 per share, the closing price of Adicet's common stock as reported by Nasdaq on March 31, 2025. One-fourth of the shares underlying each employee's option will vest on the one-year anniversary of each recipient's start date and thereafter the remaining three-fourths of the shares underlying each employee's option will vest in thirty-six substantially equal monthly installments, such that the shares underlying the option granted to each employee will be fully vested on the fourth anniversary of the recipient's start date, in each case, subject to each such employee's continued employment with Adicet on such vesting dates.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
AbbVie to Host First-Quarter 2025 Earnings Conference Call

AbbVie to Host First-Quarter 2025 Earnings Conference Call

AbbVie (NYSE: ABBV) will announce its first-quarter 2025 financial results on Friday, April 25, 2025 before the market opens. AbbVie will host a live webcast of the earnings conference call at 8 a.m. Central time . It will be accessible through AbbVie's Investor Relations website at investors.abbvie.com . An archived edition of the session will be available later that day.

About AbbVie

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Adicet Bio to Participate in 2025 Canaccord Genuity Horizons in Oncology Virtual Conference

Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced that Chen Schor, President and Chief Executive Officer, will participate in a panel at the Canaccord Genuity Horizons in Oncology Virtual Conference being held April 7, 2025.

Details of the event are as follows:
Panel: "CAR T Approaches in the Autoimmune Space"
Date: Monday, April 7, 2025
Time: 3:00 p.m. ET

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
The Radoff-JEC Group Nominates Three Highly Qualified Candidates for Election to the Atea Pharmaceuticals Board of Directors

The Radoff-JEC Group Nominates Three Highly Qualified Candidates for Election to the Atea Pharmaceuticals Board of Directors

Issues Open Letter to Atea's Stockholders Outlining the Case for Boardroom Change Based on Years of Stock Price Underperformance, Poor Decision-Making and Entrenchment Maneuvers

Believes its Three Highly Qualified Director Candidates Possess the Necessary Ownership Perspectives, Scientific Credibility and Public Company Board Experience to Create Value for Stockholders

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Allergan Aesthetics Emphasizes Commitment to Innovation, Science and a Patient Centric Approach at AMWC 2025

Allergan Aesthetics Emphasizes Commitment to Innovation, Science and a Patient Centric Approach at AMWC 2025

  • Four expert-led educational events with Allergan Medical Institute (AMI), Science of Aging TM and Allergan Aesthetics (AA) Global Medical Affairs
  • AMI symposia will focus on a new Allergan Aesthetics (AA) Signature Program and celebrate 10 years of MD Codes™, with live injection sessions and fireside chat with world-renowned plastic surgeon Dr. Maurício de Maio
  • Eleven E-Poster data presentations and Meet the Expert sessions with Global experts live from the Allergan Aesthetics booth

Allergan Aesthetics, an AbbVie company, the industry leader in aesthetics globally, demonstrates how to elevate the patient experience and achieve optimal treatment outcomes with new AA Signature program at the Anti-Aging and Aesthetics Medicine World Congress (AMWC) in Monaco from Thursday, March 27Saturday, March 29, 2025 .

Activities will center around the new AA Signature program - an innovative approach to treatment planning harnessing the power of Allergan Aesthetics advanced portfolio to address different patient needs, including Lift, Definition and Skin Quality , and a celebration of 10 years of MD Codes™, which has revolutionized aesthetic medicine with innovative methodology to guide injectors' technique and elevate patient outcomes.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Bcal Diagnostics Limited

BCAL Diagnostics Launches BREASTEST plus - Generating First Revenues

BCAL Diagnostics Limited (ASX: BDX) (“BCAL” or “the Company”), an Australian and US-based biotechnology company pioneering non-invasive breast cancer diagnostics, is pleased to announce the commercial launch of BREASTEST plus. This first-in-class blood test is available from Thursday, 27 March 2025 and will be used alongside standard-of-care imaging in breast cancer screening and diagnostics. The Company is pleased that this launch has been achieved within the previously announced target timeframe of having the test commercially available in Australia by the end of 1Q CY2025.

Keep reading...Show less

Latest Press Releases

Related News

×