United States approves remdesivir; India plans trials

the Administración de Drogas y Alimentos de the Estados Unidos ha permitido el uso de emergencia del fármaco antivírico experimental, utilizado anteriormente para el Ébola, para tratar a pacientes con Covid-19, incluso cuando la India está tratando de importar the ensayos locales para comenzar.

the drug has delivered encouraging results on patients in need of advanced care and helped quicken recovery. India , which is part of WHO’s solidarity on the drug, is exploring options to source it, official sources said. “Around four hospitals have been identified as trial sites and are waiting for ethics committee approval. We are also in the process of enrolling patients for the trial. Trials in India can start as soon as the drug arrives,” a senior official said.

There are currently limited stocks of the drug that is under different trials in several countries. However, with the authorization of the US FDA. In the US, your demand is likely to increase substantially.

Estamos trabajando para acceder al medicamento para nuestra gente y se harán todos the esfuerzos para que el medicamento esté disponible en la India si resulta beneficioso, dijo el Dr. Niti Aayog, miembro del Niti Aayog, quien también dirige el Grupo Empoderado de Respuesta a Emergencias formado por el gobierno. Covid-19, le dijo a TOI.

Experts said though the trial is significant as it is suggestive of reduction in symptomatic time, it cannot be used as a standard treatment because of limited evidence. the need for larger controlled clinical trials, which can demonstrate clear impact on hard clinical end-points, including mortality reduction, remains as search for an effective life-saving cure continues, said Dr K Srinath Reddy of Public Health Foundation of India .

El viernes, la FDA de the EE. UU. Autorizó el uso de emergencia de Remdesivir para el tratamiento de Covid-19 después de que the resultados preliminares de un estudio patrocinado por el gobierno en EE. UU. Mostraran que el medicamento de Gilead Science acortó el tiempo de recuperación en cuatro días, de 15 a 11 días. en pacientes hospitalizados con Covid-19.

La autorización de uso de emergencia permite que the productos se usen para el tratamiento sin datos completos sobre su seguridad y eficacia, que aún debe presentarse a medida que continúan the ensayos. Remdesivir es el primer medicamento del mundo que ofrece evidencia de ser efectivo para Covid-19, que ha matado a más de 2,30,000 personas en todo el mundo e infectado a más de tres millones.

Basado en la totalidad de la evidencia científica disponible para la FDA, es razonable creer que Remdesivir puede ser eficaz en el tratamiento de Covid-19 y que, cuando se usa en las condiciones descritas en esta autorización, the beneficios conocidos y potenciales de Remdesivir cuando se usa para tratar Covid-19 superan the riesgos conocidos y potenciales de tales productos; y no hay una alternativa adecuada, aprobada y disponible , dijo la FDA en la carta.

“One trial compared the 5-day regimen with the 10-day regimen and observed an equal clinical recovery time. There was no control group and the effect on deaths was not studied. Another trial was randomized, had a standard care control group, and noted a benefit in reducing recovery time from serious illness. However, the impact on death was not statistically significant and therefore has not been proven, he said.

The researchers say other trials like the WHO multi-country solidarity trial will be helpful in establishing the drug's effectiveness. While there is also a compassionate use program for Remdesivir, India is not part of it. The compassionate use program is using a new unapproved medication to treat a seriously ill patient in a setting where no other treatment is available.

An official with the drug regulator's office said drug approval is not required for such use. However, a clinical management protocol must be prepared and must be approved by ICMR.

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