USFDA Approves Molnupiravir Use in India | India News

NEW DELHI: A group of expert advisers have recommended the first home treatment for Covid-19, Molnupiravir, to the United States Food and Drugs Administration (USFDA) for approval. If the FDA grants emergency clearance for the drug, it may also pave the way for emergency use clearance for the drug in India.
Usually, the recommendations of the expert committee are accepted by the regulator. India’s Regulatory Expert Committee (SEC) withheld its recommendations mainly because the drug has yet to be approved in its home country, sources said.
Experts said the pill can play an important role if vaccine-induced and natural immunity is threatened by the new Omicron variant.
At its next meeting, the SEC will likely reconsider EUA’s request for a recommendation for the drug if additional data is deemed satisfactory, an official said.
Many Indian companies, including Natco, Dr Reddy’s, Cipla, Sun Pharma, Hetero and BDR Pharma, are awaiting regulatory approval to bring the generic antiviral into the country, which is expected to be affordable.
Development is gaining in importance as the oral antiviral pill Molnupiravir, developed by Merck and its partner Ridgeback, is touted as a change for people at high risk and people with weakened immunity and is said to have halved the risk of disease. hospitalization and death. The drug has shown promise in the treatment of mild to moderate Covid-19 in adults.
Currently, antiviral drugs used in Covid therapy, such as remdesivir, are administered intravenously and in hospital settings.
The UK’s Medicines and Health Products Regulatory Agency has already granted conditional approval to the drug. The drug is authorized in the UK for the treatment of mild to moderate Covid-19 in adults with a positive SARS-CoV-2 diagnostic test and who have at least one risk factor for developing serious illness.
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