Words by GOLD newsdesk
The European Medicines Agency (EMA) is set to perform an accelerated review of Gilead Sciences’ Marketing Authorisation and EU-Medicines for all (EU-M4all) applications for its twice-yearly injectable for HIV prevention.
The validation follows the FDA’s recent acceptance of Gilead’s New Drug Applications for the pre-exposure prophylaxis (PrEP) drug lenacapavir under priority review, marking a significant regulatory milestone.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) has assessed that the drug is a product of major interest for public health and therapeutic innovation, qualifying it for accelerated assessment by the EMA.
Commenting in a press release, Dietmar Berger, Chief Medical Officer, Gilead Sciences, said: “Achieving another key regulatory milestone so soon after the US FDA’s acceptance of our New Drug Applications for lenacapavir for PrEP underscores the great interest in how this medication, if approved, could help transform efforts to end the HIV epidemic globally.”
The EU-M4all application is being reviewed by the CHMP in parallel with the MMA. The aim is to obtain an opinion from the Committee that could speed up the regulatory process and accelerate access to this potentially life-saving medicine in low- and lower-middle-income countries.
These latest updates are in line with Gilead’s lenacapavir access strategy, which prioritises speed and enables the most efficient pathways for regulatory review, approval and access to the PrEP drug worldwide. In recognition of the drug’s potential impact, Science Magazine named it its ‘Breakthrough of the Year’ in December 2024.
