New US pill tackles persistent herpes infections
The FDA approved pritelivir for a limited group of adults with weakened immune systems.
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The US Food and Drug Administration (FDA) has approved a new oral treatment for persistent herpes simplex infections in adults with weakened immune systems. Pritelivir is intended for patients whose usual antiviral medicines do not work or are not tolerated.
In the United States, the medicine will be marketed under the brand name Hovilpri. The approval covers mucosal and skin lesions caused by herpes simplex virus in adults with weakened immune systems who respond inadequately to aciclovir, valaciclovir or famciclovir.
The FDA based its decision on a late-stage study involving 101 participants. According to the results, the skin lesions had completely healed by day 28 in 62.7 per cent of participants who received pritelivir. In the comparison group, the figure was 34 per cent. The study compared the medicine with treatments doctors used in this situation.
Pritelivir works on a different part of the virus’s replication process from older medicines. This may be relevant in infections that have become resistant to existing antiviral treatments. The approval does not mean that the virus disappears from the body or that herpes can generally be cured with this medicine.
For now, its use remains limited. The FDA has not approved the medicine for everyone with herpes, for preventive use or for children. Availability outside the United States is also not automatically secured; separate decisions by other regulators are required for that.
Reported side effects in the study included headache, diarrhoea, nausea, reduced appetite, vomiting and dizziness. The FDA and the manufacturer also mention conditions for using it in combination with certain other medicines. Treatment must therefore always be assessed through an authorised doctor and in accordance with the official product information.
The development is also commercially relevant. Pritelivir was originally developed by the German company AiCuris, which was acquired by the Japanese pharmaceutical company Asahi Kasei. The FDA approval gives Asahi Kasei a new product for a small, medically complex patient group.
The step is good news for patients for whom existing medicines fall short, but its scope is modest. The study was relatively small, the medicine is not yet available to every patient and long-term data will have to show how it performs in everyday practice.
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The approval, target group and trial results were checked directly with the FDA and independently confirmed by Reuters. The article puts the significance of the approval into context and gives no personal treatment advice.
- confirmed The FDA approved pritelivir on 9 October 2026 for certain adults with weakened immune systems. — This is stated in the official FDA announcement. source
- confirmed The approval applies to infections that do not respond to aciclovir, valaciclovir or famciclovir. — The FDA specifies these previous antiviral treatments in the indication. source
- confirmed The late-stage study involved 101 participants. — Reuters and the FDA description mention 101 participants. source
- confirmed Complete healing after 28 days occurred in 62.7 per cent, compared with 34 per cent in the comparison group. — These figures appear in Reuters’ report on the trial. source
- confirmed Pritelivir does not cure herpes by removing it from the body. — The FDA describes herpes simplex as an infection that is not eradicated by this approval. source
Editor's note
The FDA approval and the study results have been confirmed by the regulator and Reuters. The medicine is for a limited indication, is not a cure for herpes and says nothing about treatment for individual readers.Sources
- FDA Approves Drug to Treat Lesions Caused by Herpes Simplex Virus — U.S. Food and Drug Administration
- US FDA approves Asahi Kasei’s drug for persistent herpes infections — Reuters via Investing.com
- FDA approves pritelivir tablets to treat lesions from HSV — Contemporary OB/GYN