--- title: 'Regulatory Daily Summary: What Happened on October 12, 2026' headline: FDA approves Hovilpri for refractory herpes lesions description: The oral antiviral beat investigator-selected treatment in a Phase 3 study of immunocompromised adults and had fewer reported adverse reactions. url: https://thebench.bio/news/regulatory/2026-10-12 topic: regulatory date: '2026-10-12' covers: - '2026-10-12' date_published: '2026-10-12T12:02:16Z' date_modified: '2026-10-12T12:02:16Z' tags: - Regulatory sources: 1 publisher: TheBench.Bio --- # Regulatory Daily Summary: What Happened on October 12, 2026 **FDA approves Hovilpri for refractory herpes lesions** The oral antiviral beat investigator-selected treatment in a Phase 3 study of immunocompromised adults and had fewer reported adverse reactions. ## Today in brief The FDA approved Asahi Kasei Therapeutics’ Hovilpri for refractory herpes simplex virus lesions in immunocompromised adults. [1] In the 101-person trial, complete healing by day 28 occurred in 63% of patients taking Hovilpri and 34% receiving investigator-selected treatment. [1] Asahi Kasei’s chief medical officer said it is the first FDA-authorized treatment with a new mechanism for these lesions in nearly 30 years. [1] ## Hovilpri offers an oral option for refractory herpes lesions The FDA approved Hovilpri, a 100 mg pritelivir tablet, for mucocutaneous lesions caused by herpes simplex virus in immunocompromised adults whose infections do not respond to standard antivirals. [1] The indication applies whether or not resistance to those drugs has been documented. [1] In PRIOH-1 Part C, an open-label, comparator-controlled Phase 3 superiority study, 63% of 101 patients given Hovilpri had complete healing by day 28, compared with 34% given investigator-selected cidofovir, foscarnet, or imiquimod. [1] By day 42, response rates were 82% with Hovilpri and 42% with comparator treatment. [1] Adverse reactions occurred in 22% of Hovilpri recipients and 54% of comparator recipients. [1] Adverse drug reactions led 2% of Hovilpri recipients and 20% of comparator recipients to stop treatment. [1] Headache affected 6% of Hovilpri recipients and 4% of comparator recipients. [1] Hovilpri blocks the viral helicase-primase complex and acts against HSV-1 and HSV-2, including strains resistant to nucleoside analogues and foscarnet. [1] Asahi Kasei Therapeutics expects Hovilpri to become available in the United States before the end of 2026. [1] The company said the approval is the first in nearly 30 years for a treatment with a new mechanism for these lesions. [1] ## The day in numbers - **63% vs. 34%**: Complete lesion healing by day 28 with Hovilpri versus investigator-selected treatment in PRIOH-1 Part C. [1] - **82% vs. 42%**: Response rates by day 42 with Hovilpri versus comparator treatment. [1] - **22% vs. 54%**: Patients reporting adverse reactions with Hovilpri versus comparator treatment. [1] ## Also published - [One year after MFN: How US policy is reshaping the global pharma model](), pharmaphorum ## Sources 1. [FDA approves Asahi Kasei’s Hovilpri for refractory HSV](), Pharmaceutical Technology, 2026-10-12 --- TheBench.Bio wrote this from the reporting cited above, with a language model drafting and editing. [1]: