Gilead Sciences’ HIV PrEP Injectable Approved by European Commission

The European Commission (EC) has granted marketing authorization for lenacapavir, marketed by Gilead Sciences (Gilead) as Yeytuo, as a twice-yearly, injectable human immunodeficiency virus-1 (HIV-1) capsid inhibitor for pre-exposure prophylaxis (PrEP) against the risk of sexually acquired HIV-1 (1). In a press release on Aug. 26, 2025, Gilead said the lenacapavir injection is the first and only approved, twice-yearly option for PrEP in the European Union (EU)’s 27 member states, plus Norway, Iceland, and Liechtenstein.

Latest approval for lenacapavir

Lenacapavir’s use has been approved by EC in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35 kg (77 lbs.) (1). Gilead’s marketing authorization application was reviewed under an accelerated timeline by the European Medicines Agency’s Committee for Medicinal Products for Human Use, which adopted a positive opinion on the treatment in July 2025.

“Yeytuo’s rapid authorization by the European Commission underscores the rigor of our clinical data and the transformative potential of Yeytuo to help address the urgent unmet need in HIV prevention across Europe,” said Dietmar Berger, MD, PhD, chief medical officer at Gilead Sciences, in the press release (1). “This milestone is a testament to the 17 years of Gilead research that delivered this breakthrough PrEP medication, underpinned by decades of leadership in HIV innovation.”

Lenacapavir will be granted an additional year of market protection in the EU due to the new indication, and EC’s authorization follows that of FDA, in June 2025, and World Health Organization guidelines recommending twice-yearly lenacapavir as an additional PrEP option for the purpose of HIV prevention (1).

“With around 25,000 new HIV diagnoses in the EU and European Economic Area every year, it’s clear that current prevention options are not working for everyone who needs or wants them, especially among vulnerable populations,” said Jean-Michel Molina, MD, Université Paris Cité, professor of Infectious Diseases and head of the Infectious Diseases Department at the Saint-Louis and Lariboisière Hospitals, in the Gilead press release (1). “Yeytuo’s novel twice-yearly dosing schedule and high efficacy could be the transformative HIV prevention option in Europe we’ve been waiting for to help us reduce new infections and make real progress toward ending the HIV epidemic.”

Gilead’s journey in 2025 so far

Another advancement gained by Gilead earlier in 2025 was the EC’s granting of conditional marketing authorization for the company’s seladelpar, an oral, peroxisome proliferator-activated receptor-delta agonist, for the treatment of the rare liver disease primary biliary cholangitis, either in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA alone, or as a monotherapy in patients unable to tolerate UDCA (2).

However, Gilead also cut nearly 150 jobs at its Foster City, Calif., headquarters, part of a wave of layoffs in the bio/pharmaceutical industry in the first half of 2025—a reported 32% year-over-year increase in that time period (3).

On July 31, 2025, Gilead was among 17 companies in the industry to receive letters from US President Donald Trump outlining the steps each must take to lower prescription drug prices in the United States to the lowest price offered among other developed nations, known as the most-favored-nation strategy (4).

The company will be one of the participating organizations at the Partnership Opportunities in Drug Delivery conference, scheduled for Oct. 27–28, 2025 in Boston (5).

References

1. Gilead Sciences. European Commission Authorizes Twice-Yearly Yeytuo (Lenacapavir) for HIV Prevention. Press Release. Aug. 26, 2025.
2. Gilead Sciences. Gilead’s Seladelpar Granted Conditional European Marketing Authorization for the Treatment of Primary Biliary Cholangitis. Press Release. Feb. 20, 2025.
3. Cole, C. What Sarepta’s Layoffs, and Others Across Biopharma, Mean for Industry Professionals. BioPharmInternational.com, July 17, 2025.
4. The White House. Fact Sheet: President Donald J. Trump Announces Actions to Get Americans the Best Prices in the World for Prescription Drugs. WhiteHouse.gov, July 31, 2025.
5. Cole, C. PODD 2025 Unveils Agenda Highlighting Innovation in Drug Delivery Technologies. PharmTech.com, July 16, 2025.