Gilead Sciences Statement on FDA Acceptance of New Drug Application for Investigational Lenacapavir

Foster City, Calif., July 27, 2022 – Gilead Sciences today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) resubmission for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 27, 2022. 

Gilead resubmitted the NDA on June 27, 2022. The resubmission contained comprehensive Chemistry Manufacturing and Controls (CMC) data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass. The NDA is also supported by data from the Phase 2/3 CAPELLA study, which evaluated the antiviral activity of lenacapavir administered every six months as a subcutaneous injection, in combination with other antiretroviral(s), in heavily treatment-experienced people with multi-drug resistant HIV-1 infection. The submission includes extensive pre-clinical and earlier clinical research data as well.

“Lenacapavir has the potential as an important breakthrough innovation to be transformative for people with multi-drug resistant HIV whose virus is no longer effectively responding to their current therapy,” said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. “This regulatory milestone moves us one step closer to providing an innovative treatment option that could meet the unmet needs of people who have severely limited therapy choices.”

The FDA’s acceptance of the NDA resubmission as a complete response is the latest milestone in the review of lenacapavir by a major regulatory authority. The European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP) recently adopted a positive opinion in its review of lenacapavir. The final European Commission decision is expected later this year. Additional regulatory filings are anticipated to continue throughout 2022. 

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 of HIV-1 infection. The safety, efficacy and dosing of Gilead’s investigational, long-acting HIV-1 capsid inhibitor lenacapavir are being evaluated in multiple ongoing clinical studies. 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.

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 impacted 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 was recognized as the number one philanthropic funder of HIV-related programs in a report released by Funders Concerned About AIDS.

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 in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir; uncertainties relating to regulatory applications and related filing and approval timelines, including the risk that the FDA may not approve the NDA for lenacapavir for the treatment of HIV-1 infection in heavily treatment-experienced  people with multi-drug resistant HIV-1 infection and that European Commission may not grant marketing authorization for lenacapavir for the treatment of HIV-1 infection, 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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