This week, the European Commission approved the first preventive HIV drug (PrEP-type vaccine) administered once every six months to protect against infection with the HIV virus, which causes AIDS.

The drug, lenacapavir, is an injectable treatment developed by Gilead. Its approval followed an accelerated review process, after the U.S. FDA authorized it in June and the World Health Organization (WHO) recently recommended it as a new PrEP option.

Approval was based on two Phase 3 clinical trials in which lenacapavir demonstrated:

• Outstanding efficacy across diverse participant groups.

• Superior protection against HIV infection compared with the currently available oral option (tenofovir disoproxil fumarate/emtricitabine).

The WHO has already endorsed lenacapavir as an additional HIV prevention option since July, citing successful results in studies with participants from varied backgrounds.

In the PURPOSE 2 trial:

• Among 2,180 participants receiving injections, only 2 contracted HIV.

• This means 99.9% of participants were protected, reducing infection risk by 96%.

By contrast, in another trial group of 1,087 volunteers taking the standard daily oral PrEP regimen (two-drug combination), there were 9 new HIV infections. According to WHO, lenacapavir was 89% more effective than the established oral therapy.

With its innovative twice-yearly dosage and high efficacy, lenacapavir is expected to significantly strengthen HIV prevention efforts, particularly among vulnerable populations underserved by existing options. This development is of clear importance for public health.

Lenacapavir was approved in the U.S. in June, priced at approximately €11,000 per dose. In Europe, the price is expected to be considerably lower.

The European Commission’s approval applies to all EU member states, as well as Norway, Iceland, and Liechtenstein.

According to the European Medicines Agency (EMA), the drug will be available for adolescents and adults aged 16 and older.