FDA Approves Hovilpri for Herpes Simplex Virus Lesions
The approval is based on a 101-patient trial that found 62.7% of treated patients healed within 28 days, compared with 34% in the control group.
- On Friday, the FDA approved Asahi Kasei's pritelivir to treat persistent HSV lesions in immunocompromised adults who have not responded to existing antiviral therapies.
- Older first-line drugs require activation by viral enzymes, and mutations disrupting this process cause resistance; pritelivir blocks proteins the virus needs to copy genetic material.
- Data showed that 62.7% of patients receiving pritelivir experienced lesion healing within 28 days, compared to 34% in the control group using older off-label medicines.
- This approval marks the first new HSV treatment in over 2 decades, with Asahi Kasei estimating the drug could serve about 15,000 patients with weakened immune systems.
- The WHO estimates 3.8 billion people worldwide aged younger than 50 have HSV type 1, while Asahi Kasei projects peak annual sales of more than $400 million by the mid-to-late 2030s.
15 Articles
15 Articles
Hastings Tribune
Asahi Kasei Therapeutics Announces FDA Approval of HOVILPRI® (pritelivir) Tablets for Mucocutaneous HSV Lesions Refractory (With or Without Resistance) to Standard Antiviral Treatment in Immunocompromised Adults
TOKYO--(BUSINESS WIRE)--Oct 9, 2026-
US FDA approves Asahi Kasei’s drug for persistent herpes infections - Regional Media News
Oct 9 (Reuters) - The US FDA on Friday approved Japan's Asahi Kasei's drug for persistent herpes simplex virus sores in certain patients with weakened immune systems who have not responded to available antiviral treatments. • The oral drug, called pritelivir, was developed by German [...]
US FDA approves Asahi Kasei’s drug for persistent herpes infections
Oct 9 (Reuters) - The US FDA on Friday approved Japan's Asahi Kasei's drug for persistent herpes simplex virus sores in certain patients with weakened immune systems who have not responded to available antiviral treatments. • The oral drug, called pr...
New Oral Drug Approved for Herpes Lesions
(MedPage Today) -- The FDA approved pritelivir (Hovilpri) tablets to treat mucocutaneous lesions caused by herpes simplex virus (HSV) infections in immunocompromised patients who haven't responded to other treatments. Pritelivir, an oral helicase...
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