October 09, 2026
1 min read
The FDA has approved pritelivir to treat mucocutaneous lesions caused by herpes simplex virus in immunocompromised adult patients who have not responded to previous therapies.
The approval of pritelivir (Hovilpri, Asahi Kasei), an antiviral drug that the FDA granted priority review in April, was based on data from the randomized, controlled, open-label, phase 3 PRIOH-1 study. As Healio previously reported, the phase 3 trial found that pritelivir demonstrated “superior efficacy” in healing lesions in immunocompromised patients.
The FDA approved pritelivir to treat mucocutaneous lesions caused by herpes simplex virus.
The study, presented at the Conference on Retroviruses and Opportunistic Infections earlier this year, included 101 immunocompromised participants with refractory or resistant HSV. Data showed that 62.7% of patients taking pritelivir experienced lesion healing vs. 34% in the control group, for a treatment difference of 28.7 percentage points (95% CI, 8-47.1).
According to an FDA release, the drug’s most common adverse event was headache.
WHO estimates 3.8 billion people worldwide aged younger than 50 years have HSV type 1, responsible for oral herpes, and approximately 520 million individuals aged 15 to 29 years have HSV type 2, which is the primary cause of genital herpes.
In a press release earlier this year from Aicuris, which Asahi Kasei acquired in April, the company said that, upon approval, pritelivir would be the first new HSV treatment in over 2 decades.
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