FDA approves pritelivir for specified hard-to-treat HSV lesions

Revision 1 · Treatment approval · United States · Record prepared

Prepared through Iliyn’s AI-assisted editorial workflow. Source statements are not independent audits of underlying events.

Hovilpri is approved for immunocompromised adults whose herpes simplex lesions have not responded to specified antiviral therapies.

What the record says

FDA’s October 9 update describes approval of Hovilpri (pritelivir) tablets for this defined group. In a 101-adult trial, complete lesion healing by 28 days occurred in 63% receiving Hovilpri versus 34% receiving the comparator treatments.

FDA update current October 9, 2026.

Approval concerns immunocompromised adults.

The notice identifies inadequate response to acyclovir, valacyclovir or famciclovir.

Source details and supporting locations.

Practical next step

Patients with treatment-resistant HSV lesions can ask their treating clinician whether this approval is relevant to their care.

Limits and what is not established

This treats lesions in a specified patient group; it is not a cure for HSV or an approval for everyone with herpes. Headache and drug interactions are noted; prescribing information and professional assessment remain necessary.

Sources checked October 11, 2026. Later notices may change instructions or arrangements.

Original sources

U.S. Food and Drug Administration: original information

Corrections and history

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