Breakthrough Approval: Gilead's Injection to Halt HIV

The European Commission has approved Gilead Sciences' HIV-preventing drug, lenacapavir, for marketing across the EU. This twice-yearly injection, marketed as Yeytuo in Europe and Yeztugo in the U.S., shows near 100% efficacy. Gilead seeks broader global regulatory approvals and aims to support low-income regions with royalty-free agreements.

Gilead Sciences announced that the European Commission has granted marketing authorization for its groundbreaking HIV prevention injection, lenacapavir. Branded as Yeytuo in Europe, the drug will be available across the EU, following pricing agreements in each member state. U.S. regulators had already approved it under the name Yeztugo.

The EC approval allows lenacapavir's use in the European Union’s 27 member states, along with Norway, Iceland, and Liechtenstein. In the U.S., Gilead's Yeztugo costs over $28,000 annually, creating challenges with insurance coverage. However, analysts predict strong sales growth, reaching $4 billion by 2029.

Following trials demonstrating almost complete efficacy in preventing HIV, Gilead seeks regulatory clearance in other countries, including Australia and South Africa. The World Health Organization recommended lenacapavir for HIV prevention, and Gilead plans to expand access in low-income nations through collaborative efforts with the Global Fund.