One application seeks European Commission authorization; Other application would help facilitate availability in low- and lower-middle-income countries
Both applications will be assessed under Accelerated Assessment review timeline based on agency’s belief in potential public health importance of lenacapavir for HIV prevention
Foster City, Calif., February 3, 2025 – Gilead Sciences, Inc. (Nasdaq: GILD) announced the company has submitted a European Commission marketing authorization application and an EU-Medicines for All (EU-M4all) application to the European Medicines Agency as it seeks licenses for an investigational use of lenacapavir—the company’s twice-yearly injectable HIV-1 capsid inhibitor—for the prevention of HIV as pre-exposure prophylaxis.
Read the full company press release here.
Source : Gilead Sciences, Inc.
Related HIV and Co-Infections News
Get involved
Are you living with HIV/AIDS? Are you part of a community affected by HIV/AIDS and co-infections? Do you work or volunteer in the field? Are you motivated by our cause and interested to support our work?
Subscribe
Stay in the loop and get all the important EATG updates in your inbox with the EATG newsletter. The HIV & co-infections bulletin is your source of handpicked news from the field arriving regularly to your inbox.