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US FDA panel to consider Merck .’s COVID-19 antiviral drug

A panel of experts from the U.S. Food and Drug Administration will vote later Tuesday on whether to propose to authorize Merck & Co’s antiviral drug to treat COVID-19 are not.

The US drugmaker reported on Friday that the oral drug’s effectiveness in reducing hospital admissions and deaths had fallen by 30% with data available from more than 1,400 patients in the late-stage study. their. It reported about a 50% reduction a month ago using data from 775 patients.

Analysts said they still expect the drug to be approved, as drugs like Merck’s molnupiravir, developed with Ridgeback Biotherapeutics, and Pfizer’s Paxlovid have the potential to become important therapeutics that could be used. use at home as soon as COVID-19 symptoms arise.

Competitor oral therapies target parts of the virus unaltered by mutations in the new Omicron variant. They may become even more important if natural and vaccine-induced immunity is threatened by the variant.

Merck is given twice a day for five days at the onset of COVID-19 symptoms.

FDA staffers, in brief documents posted before a meeting of outside experts, did not make recommendations on whether the drug should be authorized and said they would provide an assessment. its price on new data at the meeting.

They flagged concerns about whether the drug could cause the virus to mutate and asked the panel to discuss whether the drug should be made available to a more targeted group of patients to minimize concerns. that or not.

Drugs in the same class as molnupiravir have been associated with birth defects in animal studies. Merck said similar studies of molnupiravir – for longer periods and at higher doses than used in humans – showed no effect on mammalian DNA.

“We anticipate there will be important discussion about molnupiravir’s mechanism of action and theoretical safety concerns, particularly in relation to birth defects,” said Mizuho analyst Vamil Divan. potential drug and whether the drug should be used in pregnant women or women of childbearing age.

Divan adds that more countries can contract Pfizer to buy together with another antiviral drug, ritonavir, which has reduced hospitalizations and deaths by 89 percent in one trial.

Pfizer’s experiment, like Merck’s, was stopped early due to its high success rate.

(Reporting by Manas Mishra in Bengaluru; Editing by Caroline Humer and Bill Berkrot)

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