Brincidofovir

Paul G. Auwaerter, M.D., Kathryn Dzintars, Pharm.D., BCPS

INDICATIONS

FDA

  • Treatment of human smallpox disease in adults and pediatric patients, including neonates
    • Approved by the FDA in June 2021 for the treatment of smallpox through the FDA Animal Rule.
      • Effectiveness not determined in humans.
    • Efficacy may be reduced in immunocompromised patients (based on animal data in immunodeficient animals).

NON-FDA APPROVED USES

  • Chimerix transferred exclusive rights for mpox therapy to Emergent BioSolutions in 2022.
    • The development of brincidofovir for other indications (e.g., adenovirus) was transferred to SymBio Pharmaceuticals Ltd in 2019.
      • Inquire with SymBio about non-mpox uses of brincidofovir.
    • Mpox: used usually in combination for serious infection in patients who are severely immunosuppressed.
      • Brincidofovir may be obtained by a clinician’s request to the FDA through an emergency expanded access program or an emergency IND.

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