FDA Lifts Clinical Hold on Investigational Lenacapavir for the Treatment and Prevention of HIV

All Clinical Studies Evaluating Injectable Lenacapavir to Resume –

– Decision Based on Review of Vial Compatibility Data –

Gilead Sciences, Inc. (Nasdaq: GILD) today announced the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the company's Investigational New Drug Application (IND) to evaluate injectable lenacapavir for HIV treatment and HIV pre-exposure prophylaxis (PrEP). As previously announced , the FDA had placed a clinical hold on the use of injectable lenacapavir in borosilicate vials due to a vial compatibility issue. FDA removed the clinical hold following the agency's review of Gilead's comprehensive plan and corresponding data on the storage and compatibility of lenacapavir injection with an alternative vial made from aluminosilicate glass.

Following today's decision from the FDA, all activity can resume in the clinical studies evaluating injectable lenacapavir for HIV treatment and HIV PrEP. During the clinical hold, screening and enrollment of study participants and the dosing of injectable lenacapavir were not permitted across all lenacapavir studies. Other study activities, including the monitoring of participants, the dosing of participants in comparator arms, and the dosing of oral formulations of lenacapavir continued according to the relevant study protocol. Gilead will now work with study site investigators to fully resume the lenacapavir clinical development programs as quickly as possible.

"We are pleased to have identified an alternative vial for lenacapavir, and to now advance the robust clinical program for this potential first-in-class long-acting option for HIV treatment and prevention," said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. "Today's news brings us one step closer to our goal of offering therapeutic options for the diverse communities affected by HIV as we work to end the epidemic for everyone, everywhere."

In May 2019, the FDA granted Breakthrough Therapy Designation for the development of lenacapavir for the treatment of HIV infection in heavily treatment-experienced patients with multi-drug resistance in combination with other antiretroviral drugs. Lenacapavir recently received a complete response letter (CRL) for its new drug application (NDA) in this population due to vial compatibility. Gilead is working with the FDA to discuss next steps for the potential use of lenacapavir for the treatment of HIV in this population. Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and efficacy are not established. There is no cure for HIV or AIDS.

About Lenacapavir

Lenacapavir is Gilead's potential first-in-class, investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Lenacapavir's multi-stage mechanism of action is distinguishable from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting therapy options for people living with or at risk for HIV-1. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its lifecycle and has no known cross resistance to other existing drug classes. If approved, lenacapavir would be the only HIV-1 treatment option administered twice yearly.

The safety, efficacy and dosing of Gilead's investigational, long-acting HIV-1 capsid inhibitor lenacapavir are being evaluated in multiple ongoing clinical studies, including CAPELLA, a Phase 2/3, double-blinded, placebo-controlled global multicenter study designed to evaluate the antiviral activity of lenacapavir administered every six months as a subcutaneous injection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The New England Journal of Medicine published the primary outcome results of the CAPELLA trial in its May 11, 2022 issue. ( Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection ). Through week 26, lenacapavir was generally well tolerated in CAPELLA, with no serious adverse events related to lenacapavir as determined by the study investigator. The most common adverse event observed in the trial was injection-site reactions.

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.

For 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 11 HIV medications , including the first single-tablet regimen to treat HIV and the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection. These advances in medical research have helped to transform HIV into a preventable, chronic condition for millions of people.

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships and collaborations, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

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 and complete clinical trials involving lenacapavir in the anticipated timelines or at all; the possibility of unfavorable results from ongoing and additional clinical trials involving lenacapavir; uncertainties relating to regulatory applications and related filing and approval timelines, including Gilead's ability to address the CRL to the satisfaction of the FDA and the risk that FDA may not approve the NDA for lenacapavir for the treatment of HIV infection in heavily treatment-experienced patients with multi-drug resistance in a timely manner or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir and as a result, lenacapavir may never be successfully commercialized; 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, 2022, 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.

GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc.

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
(408) 656-8793

Brian Plummer, Media
(650) 524-7708

News Provided by Business Wire via QuoteMedia

GILD
The Conversation (0)
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.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Gilead Remains Steadfast in Support for Hepatitis C Elimination Efforts

Gilead Remains Steadfast in Support for Hepatitis C Elimination Efforts

The recent national conversation on hepatitis C (HCV) is an encouraging step towards viral hepatitis elimination in the U.S. With its long history of leadership in viral hepatitis, Gilead continues to support efforts that focus on HCV elimination. Gilead is proud that its medicines have treated over four million individuals living with HCV globally. Today, some 2.4 million people are living with HCV in the U.S., even though ~95% of those treated with direct-acting antivirals (DAAs) are cured. Prices of HCV medicines have dropped significantly, and many acknowledge that price is not a barrier for most payers and patients. Curative HCV drug therapies are just one part of an elimination strategy that needs to dedicate considerable resources and attention to screening and linkage to care so that all patients in need of HCV treatment can access it in a timely manner and achieve a cure

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
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
Gilead Sciences Releases Inaugural ESG Impact Report

Gilead Sciences Releases Inaugural ESG Impact Report

Gilead Sciences recently released its inaugural Environmental, Social and Governance (ESG) Impact Report. This is an evolution of our traditional Year in Review, and uses the ESG framework to highlight the successes and achievements of the prior year

Though the report itself is new, our commitment to practicing ESG is not: We've been guided by Environmental, Social and Governance principles for more than 35 years.

News Provided by ACCESSWIRE 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

AMGEN TO PRESENT AT THE EVERCORE ISI HEALTHCONX CONFERENCE

Amgen (NASDAQ:AMGN) will present at the Evercore ISI HealthCONx Conference at 9:10 a.m. EST on Wednesday Nov. 29, 2023. Peter H. Griffith executive vice president and chief financial officer at Amgen, and Paul Burton senior vice president and chief medical officer at Amgen will present at the conference. The webcast will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.

The webcast, as with other selected presentations regarding developments in Amgen's business given by management at certain investor and medical conferences, can be found on Amgen's website, www.amgen.com , under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen's Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

AMGEN PRESENTS NEW CARDIOVASCULAR RESEARCH AT AHA 2023

New Repatha ® (evolocumab) Data Show No Decline in Cognitive Function Associated With Very Low Levels of LDL-C

Olpasiran Research Provides Further Insights Into Cardiovascular Risks Associated With Elevated Lp(a)

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
Hydralyte International (ASX:HPC)

Hydralyte International


Keep reading...Show less
double helix molecule with ETFs stock chart

5 Small Biotech ETFs to Watch (Updated 2023)

Thanks to exchange-traded funds (ETFs), investors don’t have to be tied to one specific stock. Biotech ETFs allow market participants to gain leverage in multiple biotech companies via one investment vehicle.

The life science sector can certainly be risky, and ETFs are a good way to enter more safely than by investing in standalone stocks. A key advantage is that even if one company in the ETF takes a hit, the impact will be less direct.

Below the Investing News Network takes a look at five small biotech ETFs for investors to consider. They were selected using ETFdb.com, and their total assets under management (AUM) were under US$100 million as of November 6, 2023. All other figures were also current as of that date.

Keep reading...Show less

AMGEN PRESENTS NEW RESEARCH IN EARLY PSORIATIC ARTHRITIS AT ACR 2023

FOREMOST Study Finds Oral Otezla ® (apremilast) Significantly Improved Disease Control vs. Placebo

Amgen (NASDAQ:AMGN) today announced results from the global Phase 4 FOREMOST study evaluating Otezla ® (apremilast) in patients with early oligoarticular psoriatic arthritis. FOREMOST is the first placebo-controlled study designed to specifically assess people with oligoarticular psoriatic arthritis with early disease duration of five or fewer years. Results will be presented at the American College of Rheumatology (ACR) Convergence 2023, Nov. 10-15 in San Diego .

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×