Biopharmaceutical company Gilead Sciences Inc (Nasdaq:GILD) announced on Friday that it has received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency under accelerated review for lenacapavir as a twice-yearly injectable pre-exposure prophylaxis (PrEP) to prevent HIV-1.

If approved by the European Commission, lenacapavir would become the first and only twice-yearly HIV PrEP option in the European Union. It will be marketed under the name Yeytuo.

The CHMP also adopted a positive opinion under the EU-M4all procedure, streamlining regulatory pathways for lenacapavir in low- and lower-middle-income countries through World Health Organisation prequalification.

The recommendation is supported by the Phase 3 PURPOSE 1 and PURPOSE 2 trials, in which lenacapavir demonstrated zero HIV infections in women in sub-Saharan Africa and 99.9% effectiveness among men globally.

Lenacapavir showed superiority over daily oral Truvada and background HIV incidence in both trials, with no significant safety concerns reported.

Pending final EC approval, lenacapavir will receive an additional year of market exclusivity for the new indication.

Lenacapavir is already approved in multiple countries for treatment-resistant HIV and in the United States for HIV prevention in at-risk adults and adolescents.

Gilead is pursuing a global access strategy for lenacapavir to accelerate regulatory approvals and broaden access in underserved regions.