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 –

FOSTER CITY, Calif.--(BUSINESS WIRE)--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.

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