Asahi Kasei gains FDA approval for new herpes drug Hovilpri

Patients now have a new option for treating herpes sores that do not heal with standard care. An FDA panel approved the once-daily pill from Asahi Kasei under the brand name Hovilpri. This decision came late Friday to cover adults whose lesions fail to respond to current oral antivirals.

The drug targets people with weakened immune systems who face severe infections. These patients include those undergoing transplants or living with HIV, cancer, or autoimmune disorders. In healthy individuals, the virus often causes mild symptoms or none at all.

Older antivirals can stop working because viral mutations lead to resistance. Hovilpri uses a different mechanism to block enzymes needed for viral DNA synthesis. This gives patients an oral choice where alternatives often require intravenous dosing.

Approval relied on a Phase 3 study showing significant improvement in healing by day 28. The most common side effect reported during testing was headache. Researchers found the drug superior to the physician's choice of existing treatments for this specific group.

Company leadership calls this a major advancement for immunocompromised adults. Stacy Wheeler, CEO of Asahi Kasei Therapeutics, noted it is the first novel treatment in nearly 30 years for refractory lesions. This marks a key development for persistent disease that is difficult to manage.

Hovilpri was originally developed by AiCuris Anti-Infective Cures, a Germany-based biopharmaceutical company. Asahi Kasei bought the firm for €780 million, or about $919 million, in February. This deal strengthens their presence in treating severe infectious diseases like this one.