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The US Food and Drug Administration. USA It has enabled the emergency use of the experimental remdesivir of antiviral drugs, previously used for Ebola, to treat patients with Covid-19, even when India is seeking to import the drug to launch local trials.
The medication has given encouraging results in Covid patients who need advanced care and helped speed recovery. India, which is part of the WHO solidarity trial of the drug, is exploring options for obtaining it, official sources said. “About four hospitals have been identified as test sites and are awaiting approval from the ethics committee. We are also in the process of recruiting patients for the trial. Trials in India can start as soon as the drug arrives, “said a senior official.
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.
“We are working to access the drug for our people and every effort will be made to make the drug available in India if it is beneficial,” said Niti Aayog member Dr. VK Paul, who also heads the Empowered Emergency Group. formed by the government. Response to Covid-19, he told TOI.
Experts said that although the trial is significant in that it suggests a reduction in symptomatic time, it cannot be used as a standard treatment due to limited evidence. The need for larger controlled clinical trials, which can demonstrate a clear impact on difficult clinical endpoints, including reduced mortality, continues as the search for an effective life-saving cure continues, Dr. K Srinath Reddy said from the Indian Public Health Foundation.
On Friday, the US FDA. USA He authorized the emergency use of Remdesivir for the treatment of Covid-19 after preliminary results from a government-sponsored study in the US. USA They showed that the Gilead Science drug shortened recovery time by four days (from 15 to 11 days) in patients hospitalized with Covid-19.
The emergency use authorization allows the products to be used for treatment without complete data on their safety and efficacy, which has yet to be submitted as the trials continue. Remdesivir is the world’s first drug to offer evidence of its effectiveness for Covid-19, which has killed more than 2,30,000 people worldwide and infected more than three million.
“Based on all the scientific evidence available to the FDA, it is reasonable to believe that Remdesivir can be effective in the treatment of Covid-19 and that, when used under the conditions described in this authorization, the known and potential benefits of Remdesivir when used to treat Covid-19 they outweigh the known and potential risks of such products; and there is no suitable, approved and available alternative, “the FDA said in the letter.
“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, “said Dr. Reddy.
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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The medication has given encouraging results in Covid patients who need advanced care and helped speed recovery. India, which is part of the WHO solidarity trial of the drug, is exploring options for obtaining it, official sources said. “About four hospitals have been identified as test sites and are awaiting approval from the ethics committee. We are also in the process of recruiting patients for the trial. Trials in India can start as soon as the drug arrives, “said a senior official.
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.
“We are working to access the drug for our people and every effort will be made to make the drug available in India if it is beneficial,” said Niti Aayog member Dr. VK Paul, who also heads the Empowered Emergency Group. formed by the government. Response to Covid-19, he told TOI.
Experts said that although the trial is significant in that it suggests a reduction in symptomatic time, it cannot be used as a standard treatment due to limited evidence. The need for larger controlled clinical trials, which can demonstrate a clear impact on difficult clinical endpoints, including reduced mortality, continues as the search for an effective life-saving cure continues, Dr. K Srinath Reddy said from the Indian Public Health Foundation.
On Friday, the US FDA. USA He authorized the emergency use of Remdesivir for the treatment of Covid-19 after preliminary results from a government-sponsored study in the US. USA They showed that the Gilead Science drug shortened recovery time by four days (from 15 to 11 days) in patients hospitalized with Covid-19.
The emergency use authorization allows the products to be used for treatment without complete data on their safety and efficacy, which has yet to be submitted as the trials continue. Remdesivir is the world’s first drug to offer evidence of its effectiveness for Covid-19, which has killed more than 2,30,000 people worldwide and infected more than three million.
“Based on all the scientific evidence available to the FDA, it is reasonable to believe that Remdesivir can be effective in the treatment of Covid-19 and that, when used under the conditions described in this authorization, the known and potential benefits of Remdesivir when used to treat Covid-19 they outweigh the known and potential risks of such products; and there is no suitable, approved and available alternative, “the FDA said in the letter.
“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, “said Dr. Reddy.
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.
