EE.UU. autoriza la primera pastilla anticovid mientras se disparan los casos
Washington, 23 dic (EFE).– Estados Unidos autorizó este miércoles la primera pastilla contra la covid-19, fabricada por Pfizer y que busca reducir el número de hospitalizaciones y muertes en un momento en el que la variante ómicron ha producido un aumento exponencial de contagios.
En un comunicado, la FDA especificó que la pastilla puede usarse para tratar casos moderados de coronavirus en adultos y menores de 12 años con al menos 40 kilogramos de peso y que tengan condiciones previas, como obesidad o problemas de corazón, que les ponga en riesgo de ser hospitalizados.
La pastilla de Pfizer es el primer tratamiento oral anticovid que los estadounidenses podrán tomar en sus casas y se espera que se convierta en una herramienta crucial contra la pandemia, en un momento en el que los casos se han disparado por la variante ómicron.
Hasta ahora, todos los tratamientos en EE.UU. contra la enfermedad se administraban a través de una inyección o por vía intravenosa.
La pastilla, que se venderá con el nombre de Paxlovid, solo podrá ser comprada con receta médica y los pacientes deben tomarla tan pronto como sepan que tienen la enfermedad, como máximo dentro de los cinco primeros días en los que hayan presentado síntomas, detalló la FDA en su comunicado.
Los dos principios activos del medicamento, PF-07321332 y ritonavir, que están disponibles en comprimidos separados, deben tomarse juntos dos veces al día durante cinco días.
La píldora funciona bloqueando la actividad de una encima específica que el coronavirus necesita para replicarse en el cuerpo infectado, un mecanismo similar al de la pastilla desarrollada por otra gran farmacéutica, MSD (Merck en EE.UU. y Canadá).
Se espera que la FDA también dé pronto su visto bueno a esa pastilla, aunque los datos muestran que la de Pfizer es más efectiva y tiene menos efectos secundarios.
En concreto, el ensayo clínico de Pfizer muestra que la pastilla redujo en un 89 % de los casos las muertes y hospitalizaciones en pacientes con un alto riesgo de complicaciones y, además, sus datos más recientes confirman que el medicamento es un “inhibidor potente” ante la variante ómicron.
Las píldoras están en almacenes y listas para salir
Asimismo, Pfizer se ha marcado la meta de producir 120 millones de paquetes de pastillas en 2022. Los paquetes tienen 30 píldoras y cada uno se destinaría a un paciente.
Sin embargo, todas esas dosis no estarán disponibles al mismo tiempo y Pfizer ha advertido de que su objetivo ahora mismo es tener suficientes medicamentos para 30 millones de personas para mediados del año próximo, aunque se están evaluando opciones para acelerar el proceso.
De momento, para finales de año, Pfizer estima que habrá producido 180.000 paquetes, de los que unos 60.000 ya han sido adquiridos por el Gobierno federal estadounidense.
De hecho, el Gobierno de Joe Biden ha comprado por adelantado 10 millones de paquetes de Pfizer y 3,1 de la farmacéutica MSD o Merck para cuando su píldora sea autorizada.
Aumento exponencial de contagios
La autorización llega en un momento en el que se están registrando récords de contagios en algunos lugares de Estados Unidos, donde en total el número de casos ha crecido casi un 30% en las últimas dos semanas.
Las infecciones se han disparado especialmente en el noreste del país. Por ejemplo, en la última semana, los casos han crecido un 92 % en Nueva York y un 369 % en el Distrito de Columbia, donde se halla la capital.
Los Centros de Control y Prevención de Enfermedades (CDC, en inglés) ya informaron el lunes de que ómicron es la variante predominante en EE.UU., donde entre los pasados 12 y 18 de diciembre supuso el 73,2 % de nuevos casos.
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