Gilead Receives Favorable CHMP Opinion For HIV Prevention With Twice-Yearly Lenacapavir

Gilead Sciences, Inc. (NASDAQ:GILD) is among the 11 Best GLP-1 and Weight Loss Stocks to Invest in. Gilead Sciences, Inc. (NASDAQ:GILD) has received a favorable opinion from the European Medicines Agency’s CHMP for lenacapavir (Yeytuo®), a twice-yearly injectable HIV PrEP alternative. It will be the first of its kind in the EU if it is approved. Lenacapavir has been endorsed by the CHMP under the EU-M4all process to make it easier to obtain in low- and lower-middle-income nations. The final EC ruling is anticipated later this year.

The approval recommendation for lenacapavir is supported by solid Phase 3 data from the PURPOSE 1 and 2 studies. PURPOSE 1 exhibited 100% HIV prevention in 2,134 cisgender women from Sub-Saharan Africa, while PURPOSE 2 revealed 99.9% efficacy among 2,179 cisgender men and gender-diverse people. Lenacapavir had no adverse effects and performed better in both studies than once-daily oral Truvada. This long-acting PrEP could help with significant adherence and accessibility challenges, particularly for high-risk groups, as there were over 24,700 new HIV cases recorded in the EU in 2023.

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