EC authorizes ViiV Healthcare's Apretude

The European Commission has authorized Apretude (cabotegravir long-acting [LA] injectable and tablets) for HIV prevention, from ViiV Healthcare, the specialist HIV company majority-owned by UK Pharma major GSK (LSE: GSK).

Cabotegravir is indicated in combination with safer sex practices for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in high-risk adults and adolescents (at least 12 years of age), weighing at least 35 kg. The approval comes after a positive recommendation from the European Medicines Agency’s (EMA) human medicines committee (CHMP) in July.

Cabotegravir LA injectable and tablets for PrEP is the first and only HIV prevention option approved in the European Union (EU) that reduces the number of doses needed for effective HIV prevention from 365 daily pills to as few as six injections per year. Apretude was approved in the USA for this indication in 2021.