US FDA approves Asahi Kasei's drug for persistent herpes infections

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1. 50m ago

   FDA Approves Asahi Kasei's HOVILPRI for Herpes

   The US Food and Drug Administration approved Asahi Kasei's oral medication HOVILPRI, also known as pritelivir, to treat persistent herpes simplex virus sores. The treatment targets mucocutaneous lesions in immunocompromised adults that do not respond to standard antiviral treatments such as acyclovir, valacyclovir, or famciclovir. Developed as a helicase-primase inhibitor, the drug shifts resistant herpes care from intravenous methods to an oral daily pill. Asahi Kasei gained the therapy through its acquisition of German drugmaker AiCuris Anti-Infective Cures.

   Why it matters

   Standard antiviral options often fail to clear persistent herpes lesions in patients with compromised immune systems, leaving limited alternatives. The newly approved oral tablet provides an alternative to intravenous care for drug-resistant cases. The drug achieved higher rates of complete lesion healing in clinical trials compared to investigator choice treatments.

   What is confirmed

   • The US FDA approved Asahi Kasei's drug HOVILPRI for persistent herpes simplex virus sores in immunocompromised adults.
   • HOVILPRI, chemically known as pritelivir, is an oral helicase-primase inhibitor.
   • The medication treats mucocutaneous lesions refractory to acyclovir, valacyclovir, or famciclovir.
   • The drug was developed by German drugmaker AiCuris, which Asahi Kasei acquired.
   • The approval covers patients with or without documented resistance to standard antiviral treatment.

   What to watch next

   • Commercial launch and market availability of HOVILPRI tablets
   • Pricing and insurance coverage decisions for the newly approved drug
   • Post-marketing safety and efficacy monitoring in broader patient populations
   Sources used for this update (28)

   1. consent.yahoo.com — Latest news and current events updates | Yahoo News Singapore
   2. www.yahoo.com — Yahoo
   3. Reuters — US FDA approves Asahi Kasei's drug for persistent herpes infections
   4. Dealroom — FDA approves HOVILPRI (pritelivir) for refractory HSV lesions in immunocompromised adults
   5. PharmTech.com — Pritelivir Shifts Resistant Herpes Care from Intravenous to Oral
   6. Healio — FDA approves Hovilpri for herpes simplex virus lesions
   7. FirstWord Pharma — Asahi Kasei's recently acquired helicase primase inhibitor gets FDA approval for herpes lesions
   8. Business Wire — 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
   9. Mugglehead Investment Magazine — Asahi Kasei wins FDA approval for HOVILPRI in refractory HSV
   10. Moomoo — A Drug for 15,000 Patients Just Got FDA Approval and Here is Why That is Not Small News
   11. www.empr.com — Hovilpri Wins FDA Approval for Refractory Mucocutaneous HSV
   12. pharma.economictimes.indiatimes.com — Drug Approvals & Launches
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