Panel of health experts appointed by US government votes to approve Merck's Covid pill, setting stage for likely authorisation of the first drug that Americans could take at home to treat coronavirus.
A panel of expert advisers to the US Food and Drug Administration has narrowly voted to recommend the agency authorise Merck & Co's antiviral pill to treat Covid-19.
The FDA's Antimicrobial Drugs Advisory Committee voted 13-10 on Tuesday to recommend the agency authorise the drug after discussing concerns that the drug could cause the virus to mutate as well as safety concerns about the potential for birth defects.
The US drugmaker published data last week suggesting that the drug was significantly less effective than previously thought, reducing hospitalisations and deaths in its clinical trial of high-risk individuals by around 30 percent.
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.
Both FDA staff scientists and Merck have suggested the drug should not be recommended during pregnancy.
FDA authorisation for molnupiravir could be a major step in treating the virus. It would give doctors the first drug they could prescribe for patients to take on their own, easing the burden on hospitals and helping to curb deaths.
The pill is already authorised in the UK.
Paxlovid by Pfizer
A rival drug being developed by Pfizer Inc, called Paxlovid, is particularly promising, having shown an 89 percent reduction in hospitalisations and deaths in its clinical trial. The FDA could consider that drug within the next few months.
The vote comes as fears about the new Omicron variant have rattled financial markets and sparked concerns about the strength of the global economic recovery as the world continues to fight the coronavirus pandemic.
The oral therapies target parts of the virus that are not changed by mutations in the Omicron variant.
They could become even more vital if vaccine-induced and natural immunity are threatened by the variant.