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New Oral Drug Refractory HSV FDA Approved
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https://www.businesswire.com/news/home/20261009917279/en/Asahi-Kasei-Therapeutics-Announces-FDA-Approval-of-HOVILPRI-pritelivir-Tablets-for-Mucocutaneous-HSV-Lesions-Refractory-With-or-Without-Resistance-to-Standard-Antiviral-Treatment-in-Immunocompromised-Adults
Asahi Kasei Therapeutics Announces FDA Approval of HOVILPRI® (pritelivir) Tablets for Mucocutaneous HSV Lesions Refractory (With or Without Resistance) to Standard Antiviral Treatment in Immunocompromised Adults
HOVILPRI® (pritelivir), a novel oral helicase-primase inhibitor represents the first FDA approved HSV therapy with a novel mechanism of action in nearly 30 years.1-3
Approval is supported by results from the pivotal Phase 3 PRIOH-1 trial, in which HOVILPRI demonstrated statistically superior complete lesion healing up to day 28. By Day 28, 63% of HOVILPRI-treated participants achieved complete lesion healing compared with 34% of participants receiving Investigator's Choice treatment, corresponding to an adjusted treatment difference of 28.4% (95% CI: 9.6, 47.3; p=0.0047).1,4
As an oral therapy, HOVILPRI provides a non-intravenous treatment option for eligible immunocompromised adult patients with refractory (with or without resistance) HSV infection.1
Pritelivir was granted Fast Track designation by the FDA along with Breakthrough Therapy designation and the New Drug Application received Priority Review.5,6
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