Drugs and FDA
FDA approves pritelivir for herpes lesions in immunocompromised adults
Hovilpri is approved for immunocompromised adults with herpes lesions who have not responded to other treatments.
The FDA approved Hovilpri (pritelivir) tablets for adults with weakened immune systems who have herpes simplex virus lesions and have not responded to acyclovir, valacyclovir or famciclovir, the agency said. The lesions can affect skin or mucosal surfaces, including the lips, nostrils, eyes and genitals.
Approval was based on PRIOH-1, a randomized, open-label trial of 101 immunocompromised adults. By 28 days, all lesions had healed in 63% of patients receiving Hovilpri, compared with 34% receiving an investigator’s choice of available treatments, FDA said. Treatment could continue up to 42 days if lesions were improving but not fully healed at 28 days. Headache was the most common adverse reaction.
