By Fineline Cube 
European Commission Grant – On 26 Aug 2025 Gilead Sciences (NASDAQ: GILD) announced that the European Commission (EC) has granted marketing authorization for its twice‑yearly injectable HIV‑1 capsid inhibitor, Yeytuo (lenacapavir).
Key Approval Details
| Item | Detail |
|---|---|
| Indication | Pre‑exposure prophylaxis (PrEP) for sexually acquired HIV‑1 in adults and adolescents at high risk |
| Eligibility | Adults and adolescents ≥ 35 kg |
| Regulatory Scope | EU‑27, Norway, Iceland, Liechtenstein |
| Administration | Injectable, every 6 months |
| Drug Class | Long‑acting HIV capsid inhibitor |
Why Yeytuo Is a Milestone
- First and only twice‑yearly PrEP option approved in the EU and surrounding countries.
- Convenient dosing—only two injections per year, improving adherence relative to daily oral PrEP.
- Global experience – Yeytuo builds on lenacapavir’s earlier approvals for multi‑drug‑resistant HIV treatment (Sunlenca) in the U.S., EU, Japan, and other markets.
Gilead’s Strategic Position
| Aspect | Impact |
|---|---|
| Portfolio Expansion | Adds a breakthrough prevention product to Gilead’s HIV lineup. |
| Market Leadership | Positions Gilead as the sole provider of a twice‑yearly injectable PrEP in the EU, potentially capturing a sizable share of the prevention market. |
| Patient Access | Enables high‑risk populations to receive a less burdensome preventive regimen, potentially reducing new HIV infections. |
Future Outlook
Regulatory approvals in the EU are expected to drive global commercial rollout, with Gilead targeting launch in the United Kingdom and other major markets in the next 12‑18 months. The company plans to leverage its existing manufacturing and distribution networks to support the new indication.-Fineline Info & Tech