Gilead Sciences (NASDAQ:GILD) announced Tuesday that the European Commission has approved its biannual injection for HIV prevention, marking a major regulatory achievement following its U.S. clearance earlier this year.
The medication, lenacapavir, will be marketed in Europe under the brand name Yeytuo. In the U.S., it is sold as Yeztugo, having received authorization in June.
The European approval applies to all 27 EU countries, plus Norway, Iceland, and Liechtenstein. Gilead must still finalize pricing and reimbursement agreements with each nation before the treatment becomes available to patients.
In the United States, Yeztugo has a list price exceeding $28,000 annually, a figure that has prompted some insurers to delay coverage. Analysts cited by Reuters, using LSEG data, project that the drug could generate more than $4 billion in yearly sales by 2029.
The approval allows lenacapavir to be used as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents at elevated risk. Clinical trials conducted last year demonstrated that lenacapavir was nearly 100% effective in preventing infection.
Gilead noted that its EU application underwent an accelerated review process and was granted an additional year of market exclusivity. The company has also filed for regulatory clearance in Australia, Brazil, Canada, South Africa, and Switzerland, with plans to submit applications in Argentina, Mexico, and Peru.
In July, the World Health Organization recommended lenacapavir as an additional 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.
Gilead also plans to pursue regulatory submissions in low- and middle-income countries under existing voluntary licensing agreements, covering 18 nations that account for 70% of the global HIV burden.
In collaboration with the Global Fund, the company aims to supply lenacapavir to as many as two million people in low-income regions over the next three years, as generic manufacturers scale up royalty-free production.
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