FDA Approves Gilead's New HIV Treatment For Heavily Treated With Multi-Drug Resistant Patients

The FDA has approved Gilead Sciences Inc's GILD 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 approval comes almost a week before the PDUFA date of December 27.
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.
In August, the European Commission approved lenacapavir for adults with multi-drug resistant HIV infection.
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.
The FDA lifted the hold in May after Gilead switched to aluminosilicate glass.
Price Action: GILD shares are down 0.73% at $84.65 on the last check Thursday.