Gilead Resubmits New Drug Application to U.S. Food and Drug Administration for Lenacapavir, an Investigational, Long-Acting HIV-1 Capsid Inhibitor

Rhea-AI Summary

Gilead Sciences has resubmitted the New Drug Application (NDA) for lenacapavir, a long-acting HIV-1 treatment for heavily treatment-experienced patients with multi-drug resistant infections. This follows the FDA's Complete Response Letter issued in February 2022 concerning vial compatibility issues. The resubmission includes comprehensive data on compatibility with a new vial type. If approved, lenacapavir would be the only HIV-1 treatment option administered biannually. The FDA will establish a new PDUFA date upon acceptance of this NDA.

Positive

• NDA resubmission addresses previous FDA concerns, increasing chances for approval.
• If approved, lenacapavir will be the first HIV-1 treatment option administered twice-yearly.

Negative

• FDA previously issued Complete Response Letter due to vial compatibility issues.
• The investigational drug's safety and efficacy are not yet established.

– NDA Resubmission Addresses Issues Related to Vial Compatibility –

– If Approved, Lenacapavir Would be the First and the Only HIV-1 Treatment Option Administered Twice-Yearly –

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the resubmission of the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lenacapavir, an investigational, long-acting HIV-1 capsid inhibitor, for the treatment of HIV-1 infection in heavily treatment-experienced (HTE) people with multi-drug resistant (MDR) HIV-1 infection.

Gilead resubmitted the NDA in response to the FDA Complete Response Letter (CRL) issued in February 2022, which cited Chemistry Manufacturing and Controls (CMC) issues relating to the compatibility of lenacapavir in borosilicate vials as the reason for the FDA action. The NDA resubmission contains comprehensive CMC data to support the compatibility of lenacapavir with an alternative vial type made from aluminosilicate glass. In addition, the NDA is supported by extensive pre-clinical and earlier clinical research data as well as 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.

Once accepted by the FDA, a new Prescription Drug User Fee Act (PDUFA) date will be established.

"There are people with HIV who have severely limited treatment options due to resistance to multiple antiretroviral therapy classes," said Jared Baeten, MD, PhD, Vice President, HIV Clinical Development, Gilead Sciences. "We are committed to addressing unmet needs and recognize the urgency for filling the critical treatment gap for people with multi-drug resistant HIV whose virus is no longer effectively responding to their current therapy."

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 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 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 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 the risk that the FDA may not approve the NDA for lenacapavir for the treatment of HIV-1 infection in HTE people with MDR 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.

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220627005599/en/

Jacquie Ross, Investors

investor_relations@gilead.com

Brian Plummer, Media

brian.plummer@gilead.com

Source: Gilead Sciences, Inc.

FAQ

What is the status of Gilead's lenacapavir NDA resubmission?

Gilead has resubmitted the New Drug Application (NDA) for lenacapavir to the FDA addressing vial compatibility issues.

What does lenacapavir treat?

Lenacapavir is an investigational treatment for HIV-1 infection in heavily treatment-experienced individuals with multi-drug resistant HIV-1.

When was the Complete Response Letter from the FDA issued regarding lenacapavir?

The FDA issued the Complete Response Letter for lenacapavir in February 2022.

What would be the significance if lenacapavir is approved?

If approved, lenacapavir would be the first and only HIV-1 treatment option administered twice-yearly.

How does lenacapavir work?

Lenacapavir works as a long-acting HIV-1 capsid inhibitor, acting on multiple stages of the viral lifecycle.