Gilead: CHMP Adopts Positive Opinion For Lenacapavir To Treat People With Multi-Drug Resistant HIV

(RTTNews) - Gilead Sciences, Inc. (GILD) announced the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion for investigational lenacapavir for the treatment of HIV-1 infection, in combination with other antiretroviral, in adults with multi-drug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen. The company said the positive opinion is supported by data from the phase 2/3 CAPELLA trial, a double-blinded, placebo-controlled global multicenter study.

Lenacapavir is an investigational compound and is not approved by any regulatory authority for any use.