Plural en linea
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Ciudad de México.- La Comisión Federal para la Protección contra Riesgos Sanitarios (Cofepris), autorizó para uso de emergencia el tratamiento oral molnupiravir, que será destinado para atender pacientes con Covid-19 leve o moderado, y con alto riesgo de complicaciones.
La autorización para uso de emergencia se emite de manera controlada y requiere prescripción médica, considerando las acotaciones detalladas en el oficio de autorización para evitar mal uso de este medicamento, la automedicación y/o su venta irregular.
El proceso de aprobación comenzó la semana del 23 de diciembre de 2021, cuando se tuvo intercambio de información técnica con otras agencias regulatorias. Explicó que este proceso de transferencia de conocimiento se realizó gracias al reliance, o convergencia regulatoria, declarado prioridad en Cofepris en agosto del año pasado.
El titular de Cofepris, Alejandro Svarch Pérez, resaltó que México es uno de los primeros países en autorizar el medicamento. “Esta aprobación se emite en tiempo record, ya que las agencias de regulación sanitaria en el mundo contamos con evidencia científica que nos permite evaluar esta opción terapéutica oral como segura y eficaz, que permitirá reducir las hospitalizaciones por Covid-19”.
En países como Estados Unidos y Japón el tratamiento ya cuenta con autorización; mientras que en otros como Canadá, Australia y Suiza se encuentra en proceso de análisis. Todos cuentan con agencias de autorización sanitaria consideradas como referencia internacional y, al igual que Cofepris, son integrantes de la Conferencia Internacional sobre Armonización de Requisitos Técnicos para el Registro de Productos Farmacéuticos para Uso Humano.
Personal especializado de la Comisión de Autorización Sanitaria evaluó la evidencia presentada por la empresa Merck Sharp & Dohme B.V., certificando el cumplimiento de los requisitos necesarios para garantizar calidad, seguridad y eficacia de molnupiravir.
Con base en los estudios disponibles, Cofepris determinó que este tratamiento puede recibir autorización para uso de emergencia bajo la indicación terapéutica: tratamiento de enfermedad por Covid-19 leve a moderado en adultos con prueba de diagnóstico SARS-cov-2 positiva, que no requieren oxígeno suplementario, para quienes tienen al menos un factor de riesgo de desarrollar Covid-19 grave incluyendo hospitalización o la muerte y para quienes las opciones alternas de tratamiento Covid-19 autorizadas no son accesibles o clínicamente apropiadas.
El medicamento actúa introduciendo errores en el código genético del virus SARSCoV-2, evitando que se replique en el organismo. Se trata de un medicamento oral suministrado a través de cápsulas por cinco días.
La autorización para uso de emergencia se emite con base datos de MOVe-OUT, un ensayo clínico aleatorizado, doble ciego y controlado con placebo que estudia
la efectividad del medicamento para el tratamiento de pacientes no hospitalizados con Covid-19 de leve a moderado y con alto riesgo de enfermar gravemente y ser hospitalizados.
Cofepris se sumó al llamado internacional para recordar a las personas que este tratamiento no sustituye las vacunas autorizadas contra Covid-19, y que no debe ser utilizado sin indicación médica.
En caso de identificar su libre venta al público, invitó a realizar una denuncia sanitaria a través de la página gob.mx/cofepris, ya que su consumo irregular constituye un riesgo a la salud por ser de dudosa procedencia.
(La Jornada)
