EMA has recommended granting a marketing authorisation in the European Union (EU) for Yeytuo (lenacapavir) for pre-exposure prophylaxis (PrEP) in combination with safer sex practices to reduce the risk of sexually acquired human immunodeficiency virus type 1 (HIV-1) infection in adults and adolescents at high risk of becoming infected. Yeytuo will facilitate PrEP uptake and compliance because it only has to be administered twice a year via a subcutaneous injection.

Yeytuo was evaluated by the CHMP, EMA’s human medicine committee, under an accelerated timetable because it is considered to be of major public health interest in the EU and the rest of the world. The CHMP simultaneously reviewed the medicine for the EU market, under the centralised procedure, and for non-EU countries, under the ‘EU-Medicines for all’ (EU-M4all) programme. This aims to make medicines that address unmet medical needs or are of major public health interest available in Europe and globally…