Shots:

• The MAA is based on the ongoing P-II/III CAPELLA study evaluates the antiviral activity of lenacapavir (PO- SC- every 6mos.) in combination with other antiretroviral agents vs PBO in a ratio (2:1) in 36 patients with multi-drug resistant HIV-1 infection
• Results: viral load reduction from baseline of at least 0.5 log10 copies/mL for 14-day functional monothx. period (88% vs 17%). The therapy was generally well-tolerated with no serious
• The EMA’s CHMP will review the application under the centralized licensing procedure for all 27 member states of the EU- Norway- Iceland & Liechtenstein. If approved- Lenacapavir will be the 1^st capsid inhibitor & only HIV-1 treatment option

Ref: Businesswire | Image: Gilead