Positive Opinion for New HIV Prevention Drug in Europe

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for a new injectable drug, lenacapavir, for HIV prevention.

The treatment, administered twice a year, has shown high efficacy in studies, with 100% in women in sub-Saharan Africa and 99.9% in men and people with different gender identities.

Approval is expected from the Commission within the year for EU countries, Norway, Iceland and Liechtenstein. In 2023, 24,731 new HIV diagnoses were reported in 30 EU/EEA countries, an increase of 11.8% compared to 2022.

Lenacapavir is the first and only prevention option (PrEP) administered every six months, unlike daily treatments.

Gilead Sciences, the manufacturing company, emphasized its commitment to global access to the drug and addressing the socioeconomic factors that affect HIV prevention.

A recent forum in Greece discussed the need for early diagnosis, adherence to treatments and addressing stigma.