The FDA has approvedGilead Sciences Inc’sGILD Sunlenca (lenacapavir), in combination with another antiretroviral (s) (ARV), for HIV-1 infection in heavily treatment-experienced (HTE) adults with multi-drug resistant (MDR) HIV-1 infection.
The company says that Sunlenca offers a new, twice-yearly treatment option for adults with HIV that is not adequately controlled by their current treatment regimen.
The approval is supported by data from the Phase 2/3 CAPELLA trial, which evaluated lenacapavir in combination with an optimized background regimen in people with multi-drug resistant HIV-1 who are heavily treatment-experienced.
Additional regulatory filings and decisions by regulatory authorities are anticipated to continue in 2023.
Lenacapavir for HIV prevention is investigational in multiple ongoing clinical studies.
Last year, the FDA placed a hold on ten clinical trials after finding that the vials Gilead used to hold the drug could lead to an elevated risk of glass particulates seeping into the solution.
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