Gilead’s Sunlenca (lenacapavir) Receives EC's Approval for the Treatment of HIV Infection
- The EC has granted marketing authorization for Sunlenca (capsid inhibitor) in combination with other antiretrovirals for adults with multi-drug resistant HIV inf.
- The MAA was based on the P-II/III (CAPELLA) study to evaluate the antiviral activity of lenacapavir (SC) + optimized background regimen vs PBO in a ratio (2:1) in 36 heavily treated-experienced patients with multi-drug resistant HIV-1 inf. across North America, the EU & Asia. The PDUFA action date is expected on Dec 27, 2022
- The results showed that 83% of patients achieved an undetectable viral load (<50 copies/mL) @52wk. along with a mean increase in CD4 count of 83cells/µL. The MAA will be valid in 27 member states of the EU, Norway, Iceland & Liechtenstein
Ref: Businesswire | Image: Gilead
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