Mumbai The US Food and Drug Administration (FDA) has revoked the emergency use authorization (EUA) for two antibody cocktail drugs made by Regeneron and Eli Lilly, a move that calls into question the use of these drugs in India. holds because they were approved. Efficacy was shown on the delta variant based on data submitted to the FDA.
The FDA announced on January 24 that it has revised the EUA for the drugs Regeneron and bamalanivimab by Eli Lilly and for the drugs Regene-CoV (casirivimab and imdevimab) by Eli Lilly because these drugs are “highly unlikely to be active against the Omicron variant which spreading very rapidly. High frequency across the United States”.
The FDA’s decision comes after the Centers for Disease Control assessed that more than 99% of cases in the US are of the Omicron type and an independent panel from the National Institutes of Health (NIH) also recommended against the use of these drugs because of their significant Significantly less efficacy against the Omicron variant.
The REGEN-COV cocktail, branded as Ronaprev in India, is widely used in leading private hospitals, as per the COVID guidelines of these hospitals. Mint have seen.
The use of the drug has become controversial as many experts have raised concerns over its ineffectiveness and use on people who may not need it. drug cost 60,000 in India
Swiss drugmaker Roche, which developed the drug in collaboration with Regeneron, reported Mint that it has notified drug regulators of the FDA’s recent decision to repeal the EUA and that it has posted the guidelines on the website.
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