Lenacapavir Receives Positive CHMP Opinion For People with Multi-Drug Resistant HIV

the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positve opinion recommending lenacapavir, in combination with other antiretrovirals, as a potential new twice-yearly treatment option for people with multi-drug resistant HIV.

A positive opinion by the CHMP is a formal scientific recommendation supporting potential marketing authorization across the European Union. CHMP opinions are the basis for the European Commission’s final decision regarding marketing authorization for lenacapavir, which is expected later this year.  

This positive CHMP opinion represents another important milestone for lenacapavir – one that puts us a step closer to ensuring no one is left behind at any stage of living with HIV.  If authorized, lenacapavir would be the only treatment option administered twice-yearly and would help to fill a critical unmet need for those with complex prior treatment histories.