The Priority Review

Approvals Brief

FDA approves Hovilpri for immunocompromised patients with HSV lesions

The FDA approved Hovilpri (pritelivir) tablets for adults with weakened immune systems who have mucocutaneous lesions caused by herpes simplex virus and have not responded to acyclovir, valacyclovir, or famciclovir. In a Phase 3 trial, 63% of patients treated with Hovilpri had all lesions healed by 28 days versus 34% with other medications.

Primary source

FDA approval notification, October 9, 2026

FDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus

Read the source: FDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus fda.gov

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