Gilead Announces First Global Regulatory Approval of Sunlenca® (Lenacapavir), the Only Twice-Yearly HIV Treatment Option
Gilead Sciences announced the European Commission has granted marketing authorization for Sunlenca (lenacapavir), a new HIV treatment for patients with multidrug-resistant strains. This first-in-class medication offers an innovative, long-acting option administered bi-annually, addressing a critical unmet need. In the CAPELLA study, 83% of participants achieved an undetectable viral load at Week 52. This approval follows the FDA's consideration of lenacapavir, with a PDUFA action date set for December 27, 2022, signaling a promising future for treatment options in the evolving HIV landscape.
- European Commission grants marketing authorization for lenacapavir.
- 83% of participants in CAPELLA study achieved an undetectable viral load at Week 52.
- First-in-class long-acting treatment administered bi-annually, offering new options to patients.
- Regulatory approvals may face limitations on use and could be delayed.
- Market reception of lenacapavir by physicians is uncertain.
– European Commission Grants Marketing Authorization for Sunlenca, Helping to Address a Critical Unmet Clinical Need for People with Multi-Drug-Resistant HIV Who Have Very Limited Treatment Choices –
“Lenacapavir helps to fill a critical unmet need for people with complex prior treatment histories and offers physicians a long-awaited twice-yearly option for these patients who are at greater risk of progressing to AIDS,” said
The Marketing Authorization Application (MAA) for lenacapavir is supported by data from the Phase 2/3 CAPELLA study, which evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV who are heavily treatment-experienced. In this patient population with significant unmet medical need,
“After more than three decades of driving advancements in HIV treatment and prevention, Gilead scientists have now delivered an innovative new option for long-acting care,” said Daniel O’Day, Chairman and Chief Executive Officer,
Despite the significant advances in ARV therapy, there remain numerous critical and pressing unmet needs for people with HIV. This is particularly true for people with HIV who are heavily treatment-experienced with limited therapy options and are unable to maintain virologic suppression due to resistance or challenges adhering to a complex regimen. This type of complexity further increases the chance of suboptimal adherence and treatment failure, underscoring the need for a new treatment option that is active against resistant variants of the virus with a novel mechanism of action.
Sunlenca is indicated in the
The European Marketing Authorization is the latest milestone in the review of lenacapavir by a major regulatory authority. In July, the
For important safety information for Sunlenca, including dosing and method of administration, special warnings, drug interactions and adverse drug reactions, please see the Summary of Product Characteristics (SmPC) for Sunlenca, available from the
There is currently no cure for HIV or AIDS.
About Sunlenca®
Sunlenca is a first-in-class, long-acting HIV capsid inhibitor approved in the
About CAPELLA (NCT04150068)
CAPELLA is 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. CAPELLA includes men and women with HIV-1 and is being conducted at research centers in
In CAPELLA, 36 participants with multi-class HIV-1 drug resistance and a detectable viral load while on a failing regimen were randomly allocated to receive oral lenacapavir or placebo in a 2:1 ratio for 14 days, in addition to continuing their failing regimen (functional monotherapy). An additional 36 participants were enrolled in a separate treatment cohort. Both cohorts are part of the ongoing maintenance period of the study evaluating the safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen. The primary endpoint was the proportion of participants randomly allocated to receive lenacapavir or placebo for 14 days, in addition to continuing their failing regimen, achieving ≥0.5 log10 copies/mL reduction from baseline in HIV-1 RNA at the end of the functional monotherapy period.
Following the 14-day functional monotherapy period, participants randomly allocated to receive lenacapavir or placebo, in addition to continuing their failing regimen, started open-label lenacapavir and an optimized background regimen, while those enrolled in a separate treatment cohort received open-label lenacapavir and an optimized background regimen on Day 1. This ongoing maintenance period is evaluating the additional study endpoints of safety and efficacy of subcutaneous lenacapavir administered every six months in combination with an optimized background regimen.
For further information, please see https://clinicaltrials.gov/ct2/show/NCT04150068.
About
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 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to reduce the risk of acquiring HIV infection, and the first, long-acting injectable HIV treatment medication administered twice-yearly. Our 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
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 Sunlenca (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 in a timely manner or at all; the risk that any regulatory approvals, if granted, may be subject to significant limitations on use; the risk that physicians may not see the benefits of prescribing Sunlenca; 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
Full Summary of Product Characteristics for Sunlenca are available from the EMA website at www.ema.europa.eu.
Sunlenca, Gilead and the Gilead logo are trademarks of
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/20220819005367/en/
investor_relations@gilead.com
brian.plummer@gilead.com
Source:
FAQ
What is the significance of the European Commission's approval of GILD's Sunlenca?
What were the results of the CAPELLA study for Sunlenca?
How often is Sunlenca administered?
What challenges does Gilead face after the approval of Sunlenca?