Gilead wins European approval for HIV prevention injection

Investing.com - Gilead Sciences (NASDAQ:GILD) announced Tuesday that it has received European Commission (EC) approval for its twice-yearly HIV preventive injection. This was a major regulatory milestone after the drug was approved in the US earlier this year.

The drug, known as lenacapavir, will be marketed in Europe under the name Yeytuo. The drug was approved in June for sale in the United States under the name Yeztugo.

The EC decision covers 27 EU member states, as well as Norway, Iceland and Liechtenstein. Gilead needs to negotiate pricing and reimbursement with each country for the treatment to be available.

In the United States, Yeztugo's list price is above $28,000 annually, which has led some insurers to delay providing coverage. Analysts expect the drug to generate annual sales revenue of more than $4 billion by 2029, Reuters reports based on LSEG data.

EC approval allows the drug to be used as pre-exposure prophylaxis (PrEP) in adults and adolescents at high risk of sexually acquired HIV. Large trials last year showed that lenacapavir was almost 100% effective in preventing infection.

Gilead said the EU application was reviewed on an accelerated calendar and given an additional year of market protection. The company has also applied for regulatory approval in several countries, including Australia, Brazil, Canada, South Africa and Switzerland, and plans to obtain permits in Argentina, Mexico and Peru as well.

In July, the World Health Organization recommended lenacapaviri as an additional option for HIV prevention.

Dietmar Berger, Chief Medical Officer at Gilead Sciences, said: “The rapid authorisation of YEYTUO by the European Commission highlights the rigor of our clinical data and the transformative potential of YEYTUO to address the urgent unmet need in HIV prevention across Europe.”

Berger added: “This milestone is a testament to 17 years of Gilead research, supported by decades of HIV innovation leadership, that revealed this breakthrough PrEP drug.”

The company said it plans to apply in low- and middle-income countries under existing voluntary licensing agreements covering 18 countries representing 70% of the global HIV burden.

Gilead, in partnership with the Global Fund, aims to supply lenacapavir to up to two million people in low-income countries over the next three years as generic producers ramp up royalty-free production.

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