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Pharma & Biotech

Merck's new COVID pill gets the US regulatory green light - but only just

The Food & Drug Administration sign-off light follows the decision by regulators in the UK and EU to allow molnupiravir to be prescribed on an emergency use basis

A pill that could reduce severe COVID symptoms has gained the narrow backing of US health regulators.

Merck & Co Inc (NYSE:MRK)’s antiviral treatment molnupiravir was cleared for use by a panel of experts from the Food & Drug Administration, which voted 13 to 10 in favour of the new drug.

However, the Food & Drug Administration (FDA) said the treatment should only be administered to high-risk patients over the age of 18 suffering moderate-to-severe effects of the virus.

The American green light follows the decision by regulators in the UK and EU to allow molnupiravir to be prescribed on an emergency use basis.

Initial analysis of trial data suggested the drug may reduce hospitalisations by as much as 50%.

However, that figure fell to just 30% when the data was more thoroughly analysed – and explains why US experts were split on whether to approve the new treatment.

“I voted yes but this was clearly a very difficult decision,” Michael Green, a member of the FDA advisory committee was quoted by the Financial Times as saying.

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