Shots:
- Approval was based on P-III (PURPOSE 1 & PURPOSE 2) trials of Yeytuo vs Truvada, where PURPOSE 1 showed 0 infections & 100% risk reduction in 2134 women, while PURPOSE 2 depicted 99.9% non-infection rate in 2179 pts (2 acquired HIV), showing superiority to bHIV in both trials; published in The NEJM
- Approval is valid in all 30 EEA states, with regulatory review ongoing in Australia, Brazil, Canada, South Africa as well as Switzerland & filing is underway in Argentina, Mexico & Peru
- Yeytuo has obtained an additional yr. of EU market protection for significant clinical benefit &, following an EU-M4all positive opinion for PrEP, Gilead plans accelerated LMIC filings, prioritizing 18 countries covering 70% of HIV burden
Ref: Gilead| Image: Gilead| Press Release
Related News:- Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
