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FDA revokes EUA for 2 cocktail covid drugs

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 puts the use of these drugs in India into question as they were approved on the basis of the data submitted to FDA that showed efficacy on the Delta variant.

FDA on 24 January announced that it has revised the EUA for the drugs REGEN-COV (casirivimab and imdevimab) by Regeneron and bamlanivimab and etesevimab by Eli Lily because these drugs are “highly unlikely to be active against the Omicron variant that is circulating at very high frequency throughout the United States".

FDA’s decision comes after an assessment from the Center for Disease Control that more than 99% cases in the US are of Omicron variant and also an independent panel of the National Institutes of Health (NIH) recommended against the use of these drugs because of their significantly reduced efficacy against the Omicron variant.

In India the REGEN-COV cocktail, branded as Ronapreve, is widely used across leading private hospitals, according to covid guidelines of these hospitals that Mint has viewed.

The use of the drug has become controversial as several experts have raised concerns over its ineffectiveness and use on those who might not need it. The drug costs ₹60,000 in India.

Swiss drug maker Roche, which has developed the drug along with Regeneron, told Mint that it has communicated to the drug regulators about the recent decision by FDA on the revocation of the EUA and it has posted the guidelines on the website.Never miss a story! Stay connected and informed with Mint. Download our App Now!!

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