FDA Approves HOVILPRI® for Refractory HSV Lesions in Immunocompromised Adults

The U.S. Food and Drug Administration (FDA) has granted accelerated approval to HOVILPRI® (pritelivir) 100 mg tablets for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection that is refractory to standard antiviral treatments (acyclovir, valacyclovir, or famciclovir) in immunocompromised adults. This novel oral helicase-primase inhibitor is the first FDA-approved HSV therapy with a new mechanism of action in nearly 30 years, offering a non-intravenous option for patients with persistent, difficult-to-treat disease. The approval is supported by results from the pivotal Phase 3 PRIOH-1 trial, which demonstrated statistically superior complete lesion healing with HOVILPRI compared to investigator's choice treatment.