merck: FDA panel backs first-of-a-kind Covid-19 pill from Merck – Times of India
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WASHINGTON: A panel of US health advisers narrowly backed the benefits of a closely watched COVID-19 pill from Merck, setting the stage for a likely authorisation of the first drug that Americans could take at home to treat the virus.
A Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy.
The group’s recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age.
The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated patients, who weren’t part of the study and haven’t been shown to benefit from the medication.
The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end.
The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and US officials brace for the arrival of the new omicron variant. It is already authorised for emergency use.
Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus.
But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans.
“With no data saying it works with new variants I really think we need to be careful about saying that this is the way to go,” said Dr David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug.
The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier.
A Food and Drug Administration panel voted 13-10 that the drug’s benefits outweigh its risks, including potential birth defects if used during pregnancy.
The group’s recommendation came after hours of debate about the drug’s modest benefits and potential safety issues. Experts backing the treatment stressed that it should not be used by anyone who is pregnant and called on FDA to recommend extra precautions before the drug is prescribed, including pregnancy tests for women of child-bearing age.
The vote specifically backed the drug for adults with mild-to-moderate COVID-19 who face the greatest risks, including older people and those with conditions like obesity and asthma. Most experts also said the drug shouldn’t be used in vaccinated patients, who weren’t part of the study and haven’t been shown to benefit from the medication.
The FDA isn’t bound by the panel’s recommendation and is expected to make its own decision before year’s end.
The drug, molnupiravir, could provide a much-needed weapon against the virus as colder weather pushes case counts higher and US officials brace for the arrival of the new omicron variant. It is already authorised for emergency use.
Merck hasn’t specifically tested its drug against the new variant but said it should have some potency based on its effectiveness against other strains of coronavirus.
But that uncertainty frustrated many panelists as they grappled with whether to back the treatment for millions of Americans.
“With no data saying it works with new variants I really think we need to be careful about saying that this is the way to go,” said Dr David Hardy of Charles Drew University School of Medicine and Science, who ultimately voted to back the drug.
The panel’s narrow-but-positive recommendation came despite new data from Merck that paint a less compelling picture of the drug’s effectiveness than just a few weeks earlier.
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