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
Click here to read the full press release
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 [email protected].