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Gilead Sciences’ Sunlenca Gains FDA Approval for HIV Type 1

The FDA has granted approval to Gilead Sciences’ Sunlenca (lenacapavir) for treatment of adults with human immunodeficiency virus (HIV) type 1 whose HIV infections can’t be treated with other available options because of resistance, intolerance or safety issues.

Sunlenca belongs to the capsid inhibitors drug class and blocks the HIV-1 virus protein shell.

The agency approval was supported by results from a phase 2/3 study, with 87.5 percent of participants taking Sunlenca experiencing a decrease in virus compared to 16.7 percent of participants taking placebo.

The FDA previously granted Sunlenca Priority Review, Fast Track and Breakthrough Therapy nods for this indication.

December 27, 2022

https://www.fdanews.com/

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