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Investing.com -- Gilead Sciences (NASDAQ:GILD) said Tuesday it has received European Commission (EC) approval for its twice-yearly injection to prevent HIV, a key regulatory milestone following its U.S. clearance earlier this year.
The drug, known as lenacapavir, will be marketed in Europe under the name Yeytuo. It was authorized in June in the U.S., where it is sold as Yeztugo.
The EC decision covers all 27 EU member states, as well as Norway, Iceland, and Liechtenstein. Gilead still needs to negotiate pricing and reimbursement with each country before the treatment becomes available.
In the U.S., Yeztugo carries a list price above $28,000 a year, a cost that has led some insurers to delay coverage. Analysts expect the medicine to generate more than $4 billion in annual sales by 2029, according to Reuters, citing data from LSEG.
The EC approval allows the drug to be used as pre-exposure prophylaxis (PrEP) to reduce sexually acquired HIV in adults and adolescents at increased risk. Large trials last year showed lenacapavir was nearly 100% effective in preventing infection.
Gilead said its EU application was reviewed on an accelerated timeline and granted an additional year of market protection. The company has also filed for regulatory approval in countries including Australia, Brazil, Canada, South Africa, and Switzerland, with plans to seek authorizations in Argentina, Mexico, and Peru.
In July, the World Health Organization recommended lenacapavir as an added option for HIV prevention.
“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, Chief Medical Officer at Gilead Sciences.
“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," he added.
The company said it intends to pursue submissions in low- and middle-income nations under existing voluntary licensing agreements, covering 18 countries that represent 70% of the global HIV burden.
Working with the Global Fund, Gilead aims to supply lenacapavir to up to two million people in low-income countries over the next three years, as generic manufacturers ramp up royalty-free production.