Ciencia: Japón da luz verde a un medicamento para sanar la gripe en 24 horas

469
2025

 

Los resultados clínicos muestran que Baloxavir marboxil permite tratar la gripe en 24 horas.

Tras lograr la aprobación preliminar en Japón, las farmacéuticas Shionogi y Roche preparan la documentación para solicitar su autorización en Estados Unidos y Europa.

La gripe ha causado estragos en España durante las últimas semanas. El informe más reciente de la Red Nacional de Vigilancia Epidemiológica ha destacado la difusión epidémica del virus, que ha afectado especialmente a regiones como País Vasco, Navarra, La Rioja, Aragón y Cataluña.

 

La efectividad de la vacuna contra la gripe ha caído al 25% este año, frente a los porcentajes habituales que rondan el 40-60%. Esta baja eficacia se debe a la alta capacidad de mutación que tiene el virus de la gripe, un agente infeccioso que se ha rebelado en la última temporada, dejando a los sanitarios sin armas para combatir la enfermedad.

Aunque la vacuna contra la gripe es la medida más destacada para combatir la infección, numerosas investigaciones trabajan para desarrollar un fármaco que pueda curar la patología. Al igual que ocurre con los resfriados, la gripe está causada por un virus, lo que impide el tratamiento con antibióticos, que solo son eficaces para tratar enfermedades provocadas por bacterias. Ahora un medicamento experimental aprobado de forma preliminar en Japón ofrece nuevas esperanzas en la lucha contra la gripe.

Un nuevo medicamento contra la gripe

La empresa farmacéutica Shionogi ha desarrollado el fármaco Baloxavir marboxilcon la colaboración de la multinacional suiza Roche. El tratamiento experimental, que ha recibido el código S-033188, ha sido estudiado como medicamento contra la gripe tipo A y tipo B. A diferencia de otras terapias que ya existen en el mercado, como el famoso Tamiflu u oseltamivir, el Baloxavir marboxil es una pastilla que se administraría una sola vez por vía oral, reduciendo las posibilidades de que aparezcan resistencias al tratamiento.

 

“Es una píldora de un solo uso, en comparación con un tratamiento de varios días, lo que podría conferir ciertas ventajas para la planificación ante pandemias. No tienes el problema de una potencial resistencia que podría aparecer si no completas una terapia”, explicó Daniel O’Day, director del Departamento Farmacéutico de Roche en declaraciones a Bloomberg. El medicamento experimental Baloxavir marboxil bloquea una proteína que el virus necesita para replicarse en el interior de las células hospedadoras.

 
 

Shionogi ha completado recientemente un ensayo clínico en fase III para determinar la seguridad y la eficacia del Baloxavir marboxil en comparación con placebo y con oseltamivir. La farmacéutica no ha publicado aún los resultados del estudio en la base de datos de Clinical Trials, pero sus conclusiones positivas, presentadas el año pasado en un congreso, han logrado que el Gobierno de Japón aprobase de forma preliminar el tratamiento experimental.

Según el estudio en fase III, los pacientes que recibieron Baloxavir marboxil experimentaron una resolución más rápida de la fiebre en comparación con el placebo (24,5 frente a 42 horas). Además, los voluntarios que tomaron la píldora de Shionogi tardaron algo menos de dos días que el placebo en recuperar el estado de salud que tenían antes de ser infectados por el virus de la gripe. La farmacéutica nipona también defendió por aquel entonces que este nuevo tratamiento se toleraba mejor que el oseltamivir, provocando una “disminución significativa de la incidencia de los efectos adversos relacionados con el tratamiento”.

Tras conseguir la aprobación preliminar en Japón, Shionogi está preparando ahora la documentación necesaria para solicitar la autorización en Estados Unidos y la Unión Europea, un paso previo antes de que la terapia pudiera ser comercializada en estas regiones. Según Wall Street Journal, la Administración de Medicamentos y Alimentos​​ de EE.UU. (FDA, por sus siglas en inglés) podría dar una respuesta no antes de 2019, sin que se conozca por el momento qué ocurrirá en el viejo continente con este prometedor medicamento.

 

 

 

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