RESUMO
The development and approval of brincidofovir for the treatment of smallpox, a disease that was eradicated from the world over 40 years ago, has resulted in the second antiviral approved via the Medical Countermeasure Initiative (MCMi) to combat this disease. Approval of brincidofovir required a unique regulatory approach based on the FDA Animal Rule, and development was supported by many years of research and collaboration among academic investigators, the pharmaceutical industry and multiple government agencies. This article summarizes the FDA regulatory pathway and describes the challenges involved.
Assuntos
Antivirais/uso terapêutico , Citosina/análogos & derivados , Aprovação de Drogas , Organofosfonatos/uso terapêutico , Varíola/tratamento farmacológico , Animais , Citosina/uso terapêutico , Erradicação de Doenças , Modelos Animais de Doenças , Humanos , Medição de Risco , Resultado do Tratamento , Estados Unidos , United States Food and Drug AdministrationRESUMO
The development and ultimate approval of tecovirimat for the antiviral treatment of smallpox, a disease that has been eradicated from the world for nearly 40 years, required a unique regulatory approach based on the US Food and Drug Administration's Animal Rule. We summarise the regulatory pathway and describe the challenges involved.