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(Reuters) -A panel of expert advisers to the U.S. Food and Drug Administration will vote later on Tuesday on whether to recommend authorization of Merck & Co’s antiviral pill to treat COVID-19.
The U.S. drugmaker reported on Friday that the pill’s efficacy in reducing hospitalizations and deaths had dropped to 30% with data available from over 1,400 patients in its late-stage study. It had reported about a 50% reduction a month ago using data from 775 patients.
Still, medicines like Merck’s molnupiravir, developed with Ridgeback Biotherapeutics, are likely to become important therapeutic tools that people will be able to take at home as soon as COVID-19 symptoms arise.
A rival drug being developed by Pfizer Inc (NYSE:PFE), called Paxlovid, is particularly promising, having shown an 89% reduction in hospitalizations and deaths in its clinical trial.
The oral therapies target parts of the virus that are not changed by mutations in the new Omicron variant. They could become even more vital if vaccine-induced and natural immunity are threatened by the variant.
“As we enter the winter months, another surge is imminent, potentially in the setting of emerging new variants of concern,” Merck scientist Nicholas Kartsonis told the panel.
“We remain in dire need of novel effective well-tolerated and conveniently-administered therapies.”
Merck’s drug is likely to work in the same way against any coronavirus variant, company executives said at the meeting.
The Merck pill is meant to be taken twice a day for five days upon onset of COVID-19 symptoms.
The FDA’s staff, in briefing documents posted ahead of the meeting of outside experts, did not make a recommendation on whether the drug should be authorized.
They flagged concerns over whether it could cause the virus to mutate, and asked the panel to discuss if a more targeted population of patients should be offered the medicine.
Drugs in the same class as molnupiravir have been linked to birth defects in animal studies. Merck has said similar studies of molnupiravir – for longer and at higher doses than used in humans – indicate the drug does not affect mammalian DNA.
The FDA said, in order to address those concerns, the drug could be recommended for a specific population such as those at high risk of severe COVID-19.
