Approval Date: 09-October-2026
Regulatory Authority: U.S. Food and Drug Administration (USFDA)
Applicant: AiCuris Anti-infective Cures AG
Application Type: New Drug Application (NDA 221154)
Active Ingredient: Pritelivir
Therapeutic Area: Infectious Diseases | Antiviral Therapy
The U.S. Food and Drug Administration (USFDA) approved HOVILPRI (pritelivir) tablets on 09 October 2026 for the treatment of mucocutaneous lesions caused by herpes simplex virus (HSV) infection in immunocompromised adults whose infection is refractory, with or without documented resistance, to treatment with acyclovir, valacyclovir, or famciclovir.
Key Highlights
- Novel mechanism of action: Pritelivir is a helicase-primase inhibitor that targets the herpes simplex virus replication process.
- Target patient population: Immunocompromised adults with difficult-to-treat mucocutaneous HSV infections.
- Regulatory pathway: Approved under NDA 221154.
- Post-approval requirements: The FDA has required additional postmarketing studies to assess potential resistance-associated changes and antiviral activity against specific HSV variants. Pediatric studies are also subject to postmarketing requirements.
Regulatory Significance
The approval introduces a new oral treatment option for immunocompromised adults with refractory HSV infections, addressing an important unmet medical need. Pritelivir’s distinct mechanism of action also represents a notable development in antiviral treatment for patients who do not respond adequately to existing therapies.
Source: https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/221154Orig1s000ltr.pdf https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=221154