Health · Pharma & Biotech · 10 hrs ago
FDA approves first new oral antiviral for resistant herpes in nearly 30 years
The US Food and Drug Administration has approved pritelivir, an oral drug for adults with weakened immune systems whose herpes simplex lesions do not respond to standard antivirals.
Herpes is usually manageable, but it can become severe and persistent for people with conditions such as HIV or cancer, or those who have had transplants.
Until now, when common oral medicines failed, treatment options included drugs given intravenously.
Pritelivir works in a different way from older herpes medicines, targeting a viral protein complex needed to copy the virus’s genetic material.
In a trial of 101 adults, 62.7% of those given pritelivir had complete healing of their lesions within 28 days, compared with 34% receiving existing treatment options.
The approval is the first for a herpes drug with a new mechanism of action in nearly 30 years.
The manufacturer expects the medicine to be available in the United States before the end of the year.
The US Food and Drug Administration approved pritelivir, marketed as HOVILPRI, for adults with weakened immune systems whose herpes simplex lesions did not respond to standard antivirals.
The approval, announced on October 9, marks the first new mechanism of action for an HSV drug in nearly 30 years.
Prit elivir acts on the virus’s helicase-primase complex, unlike earlier approved HSV antivirals.
In a phase 3 trial, 62.7% of patients treated with pritelivir had complete lesion healing within 28 days, compared with 34% in the comparison group.
The FDA based its decision on a study of 101 adults with HSV infections resistant or unresponsive to available treatment.
- Who
- The FDA approved pritelivir, developed by AiCuris and marketed by Asahi Kasei Therapeutics.
- What
- The drug was approved for adults with weakened immune systems whose mucocutaneous HSV lesions did not respond to acyclovir, valacyclovir or famciclovir.
- When
- The approval was announced on October 9; the article was published on October 12, 2026.
- Where
- United States.
- Why
- It offers an oral treatment option for patients whose HSV does not respond to first-line antivirals.
This story does not have two clearly opposing sides.
Asahi Kasei acquired AiCuris, the German pharmaceutical company that originally developed pritelivir.
The FDA approved pritelivir for adults with weakened immune systems whose HSV lesions did not respond to first-line antivirals.
- Drug
- Pritelivir, marketed as HOVILPRI
- FDA approval
- October 9, 2026
- Eligible patients
- Adults with weakened immune systems and HSV lesions unresponsive to first-line antivirals
- Trial size
- 101 adult participants
- Healing within 28 days
- 62.7% with pritelivir; 34% with comparison treatments
What people are saying
HOVILPRI offers a new oral treatment option for adult patients with a persistent and difficult-to-treat disease
Sources
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