Regulatory Daily Summary
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