Gilead's Twice-yearly HIV Drug Sunlenca Gets European Commission Approval

Gilead Sciences Inc. (GILD) said on Monday that the European Commission has approved Sunlenca injection and tablets for the treatment of HIV infection, in combination with other antiretrovirals, in adults with multi-drug resistant HIV.

Sunlenca, known generically as Lenacapavir, is a first-in-class capsid inhibitor.

The European Commission approval applies to all 27 member states of the European Union, as well as Norway, Iceland and Liechtenstein. The drug will now be the only twice-yearly treatment for people who struggle with multi-drug resistant HIV.

In the U.S., Lenacapavir, proposed for the treatment of HIV-1 infection in heavily treatment-experienced people with multi-drug resistant HIV-1 infection, is under FDA review, with a decision due on December 27, 2022.

This is Lenacapavir's second go-around with the FDA. The U.S. regulatory agency had refused to approve Lenacapavir in March of this year, citing issues related to compatibility of vials and Lenacapavir solution.

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