Gilead’s Sunlenca (lenacapavir) Receives the US FDA’s Approval for Multi-Drug Resistant HIV
- The US FDA has approved Sunlenca (HIV capsid inhibitor) + other antiretroviral(s) for HIV-1 inf. in 36 heavily treatment-experienced adults with MDR HIV-1 inf.
- The approval was based on the P-II/III trial (CAPELLA) results evaluating lenacapavir (q6mos., SC) + optimized background regimen in a ratio (2:1) at research centers in North America, EU & Asia where 83% achieved an undetectable viral load (<50 copies/mL) @52wk. with a mean increase in CD4 count of 82 cells/µL. The results were presented at CROI 2022
- The therapy received BTD from the US FDA for HIV-1 inf. The EMA will be valid in 27 member states of the EU, Norway, Iceland & Liechtenstein while additional regulatory filings & regulatory authorities’ decisions are expected in 2023
Ref: Gilead | Image: Gilead
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