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Gilead’s Sunlenca (lenacapavir) Receives the US FDA’s Approval for Multi-Drug Resistant HIV

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Gilead’s Sunlenca (lenacapavir) Receives the US FDA’s Approval for Multi-Drug Resistant HIV

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  • 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

Related News:- Gilead’s Sunlenca (lenacapavir) Receives EC's Approval for the Treatment of HIV Infection

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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