Gilead Receives Full Response Letter from US FDA for Investigational Lenacapavir Due to Vial Compatibility Issues

FOSTER CITY, Calif.–(BUSINESS WIRE)–Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) for the New Drug Application (NDA) for lenacapavir, an investigational long-acting HIV-1 capsid inhibitor under investigation for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with HIV-1 infection Multidrug-resistant (MDR) HIV-1.

In the CRL, the FDA cited manufacturing and chemistry control (CMC) issues related to the compatibility of lenacapavir with the proposed container vial as the reason for their action. As previously announced, the FDA has raised questions about borosilicate glass vials and their compatibility with lenacapavir solution, resulting in a clinical hold of lenacapavir injection.

“Gilead intends to provide the FDA with a complete plan and corresponding data for using a different type of vial. We look forward to discussing this further with the FDA over the coming months so that we can make this experimental new therapy available to people living with multidrug-resistant HIV as soon as possible,” said Merdad Parsey, MD, PhD, MD -chief at Gilead. Sciences. “People living with multidrug-resistant HIV need new treatment options and we will continue to seek approval for lenacapavir to provide a much-needed new long-acting treatment option for this population.

Lenacapavir’s NDA was submitted to the FDA for the treatment of people with high treatment experience with multidrug-resistant HIV in June 2021 and selected for priority review due to high unmet need in this population. the submission was supported by data from the Phase 2/3 CAPELLA trial, which evaluated the safety and efficacy of lenacapavir administered subcutaneously every six months in combination with optimized background antiretroviral therapy in heavily pretreated people with multidrug-resistant HIV-1 infection. New clinic Data on lenacapavir were presented at the 29th Conference on Retroviruses and Opportunistic Infections (Virtual CROI 2022). Results from week 52 of the CAPELLA trial demonstrated that lenacapavir, given subcutaneously every six months in combination with other antiretrovirals, achieved high rates of virologic suppression and clinically meaningful increases in the number of CD4 in people living with HIV whose virus no longer responded effectively to their current therapy. In the CAPELLA study, the most frequently observed adverse events were injection site reactions (63%), nausea and diarrhea (13% each) and COVID-19 (11%).

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use and its safety and effectiveness are not established. There is no cure for HIV or AIDS.

About Lenacapavir

Lenacapavir is Gilead’s first investigational long-acting HIV-1 capsid inhibitor in development for the treatment and prevention of HIV-1 infection. Lenacapavir’s multi-step mechanism of action is distinct from currently approved classes of antiviral agents and is designed to provide a new avenue for the development of long-acting treatment options for people living with or at risk of contract HIV-1. While most antivirals work at only one stage of viral replication, lenacapavir is designed to inhibit HIV-1 at multiple stages of its life cycle and has no known cross-resistance with other existing drug classes. If approved, lenacapavir would be the only HIV-1 treatment option given twice a year.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has been pursuing and achieving breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all. 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, advancing research into treatment, prevention and a cure. Gilead researchers have developed 11 HIVs medications, including the first single-pill regimen to treat HIV and the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of contracting HIV infection. These advances in medical research have helped turn HIV into a preventable chronic disease for millions of people.

Gilead is committed to pursuing scientific innovation to provide solutions to the ever-changing needs of people affected by HIV around the world. By partnerships and collaborations, the company also aims to improve education, expand to access and breaking down barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

Gilead operates in more than 35 countries around the world, with headquarters in Foster City, California.

Forward-looking statements

This press release contains 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 provide the requested documentation and respond to comments in the CRL satisfactory to the FDA; the risk that the FDA will not approve the NDA for lenacapavir for the treatment of HIV-1 infection in HTE individuals with MDR HIV-1 infection in a timely manner or at all; Gilead’s ability to initiate, advance and complete clinical trials involving the injectable formulation of lenacapavir for the treatment and prevention of HIV on schedule or at all; the possibility of adverse results from ongoing and additional clinical trials involving lenacapavir; uncertainties related to regulatory submissions and related filing and approval timelines, including the risk that the FDA may not lift clinical holds for the injectable formulation of lenacapavir for the treatment of HIV and PrEP; the possibility that Gilead makes a strategic decision to discontinue development of lenacapavir and, as a result, that 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the United States Securities and Exchange Commission. -United. 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 considered forward-looking statements. The reader is cautioned that these forward-looking statements are not guarantees of future performance and are 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 undertakes no obligation and disclaims any intention to update such forward-looking statements.

GILEAD and the GILEAD logo are trademarks of Gilead Sciences, Inc. All other trademarks are the property of their respective owners.

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.

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