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

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  • 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.
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