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Gilead Granted Marketing Authorization for Twice-Yearly HIV PrEP Shot in Europe

Accelerated EC Decision Comes After U.S. FDA Approval in June.

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By: Charlie Sternberg

Associate Editor

The European Commission (EC) has granted marketing authorization for Yeytuo (lenacapavir)—Gilead Sciences Inc.’s twice-yearly injectable HIV-1 capsid inhibitor—for use as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 in adults and adolescents with increased HIV-1 acquisition risk who weigh at least 35kg. The marketing authorization application (MAA) was reviewed under an accelerated timeline based on the assessment by the European Medicines Agency’s (EMA) Commi...

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