FDA approves Hovilpri for refractory HSV in immunocompromised adults

The U.S. Food and Drug Administration has approved Hovilpri (pritelivir) for treating mucocutaneous lesions caused by herpes simplex virus infection in immunocompromised adults who have not responded to standard treatments. This approval marks the first FDA-approved HSV therapy with a novel mechanism of action in nearly 30 years, as announced by Asahi Kasei Therapeutics.

Hovilpri is a helicase-primase inhibitor developed by AiCuris Anti-infective Cures AG, now part of Asahi Kasei Therapeutics, and is indicated for immunocompromised adults with HSV infection refractory to acyclovir, valacyclovir, or famciclovir. The approval is based on results from the Phase 3 PRIOH-1 trial, which showed that Hovilpri-treated participants achieved a higher rate of complete lesion healing compared to those receiving Investigator’s Choice treatment.

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