What's Happening?
Gilead Sciences has received a positive opinion from the CHMP of the European Medicines Agency for lenacapavir, a twice-yearly injectable HIV-1 capsid inhibitor, for pre-exposure prophylaxis (PrEP). If approved, lenacapavir will be the first twice-yearly PrEP option in the EU. The decision is expected later this year, and the drug could also be available in low- and lower-middle-income countries through the EU-M4all procedure.
Why It's Important?
Lenacapavir represents a significant advancement in HIV prevention, offering a long-acting alternative to daily oral PrEP. This could improve adherence and accessibility, particularly for populations with high barriers to healthcare. The drug's approval could help reduce new HIV infections, aligning with the EU's target to end new HIV cases by 2030. It also reflects Gilead's commitment to expanding HIV prevention options globally.
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What's Next?
The European Commission will review the CHMP's recommendation, with a decision expected by the end of the year. If approved, Gilead will work on distribution strategies to ensure broad access across the EU and in low-income regions. The company will also continue its global regulatory filings and partnerships to facilitate lenacapavir's availability worldwide.
