TOKYO (dpa-AFX) - Asahi Kasei Therapeutics, the specialty pharmaceutical arm of Japan's Asahi Kasei Corporation (AHKSF, 3407.T), secured U.S. Food and Drug Administration approval for HOVILPRI (pritelivir) 100 mg tablets, marking a significant advance in the treatment of difficult-to-manage herpes simplex virus (HSV) infections in immunocompromised adults.
The newly approved therapy is indicated for the treatment of mucocutaneous lesions caused by HSV infections that are refractory, with or without documented resistance, to standard antiviral treatments including acyclovir, valacyclovir, and famciclovir. HOVILPRI is a first-in-class helicase-primase inhibitor developed by AiCuris Anti-infective Cures AG, which is now part of Asahi Kasei Therapeutics.
The FDA approval was supported by data from the pivotal Phase 3 PRIOH-1 Part C trial, a randomized, open-label, comparator-controlled study involving immunocompromised adults with treatment-refractory HSV infections. The study demonstrated the superiority of pritelivir over existing therapies in patients whose infections were resistant or unresponsive to currently available antiviral medications.
HSV infections are generally mild or asymptomatic in healthy individuals. However, people with weakened immune systems, including organ and stem cell transplant recipients, people living with HIV, and patients with cancer or autoimmune diseases, can experience more frequent, severe, and persistent infections. Drug-resistant HSV can lead to prolonged and difficult-to-treat mucocutaneous lesions, creating a significant unmet medical need.
Asahi Kasei Therapeutics expects HOVILPRI to become commercially available in the United States before the end of 2026, offering physicians a new tool to address a challenging patient population with limited treatment alternatives.
AHKSF closed Friday's regular trading at $10.30 up $0.26 or 2.62%.
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