FDA panel review – The Denver Post – Denver, Colorado

Denver, Colorado 2021-11-30 09:24:07 –

Washington — The experimental COVID-19 drug, which could be the first US-approved pill to treat coronavirus, faces one final hurdle on Tuesday. A panel of government experts will scrutinize data on drugs from the pharmaceutical company Merck.

The Food and Drug Administration asks outside experts if they need to approve the pill, considering new information that it is less effective than originally reported and can cause birth defects. I have. Panel recommendations are non-binding, but often lead to FDA decisions.

The meeting on Tuesday will be held as US infectious diseases increase again and health authorities around the world are scrambling to scale up the threat posed by the new Omicron variants.

If approved, Merck pills are the first US patients to be able to take home to relieve symptoms and speed recovery and are a major step in reducing hospital cases and mortality. ..The drug Molnupiravir is licensed for emergency use in the United Kingdom

Given the ongoing pandemic threat, the FDA is widely expected to approve the emergency use of Merck tablets. But new data released last week depicts a less convincing picture of the drug than when Merck published its first results in October.

Merck said on Friday that final study results showed that molnupiravir reduced hospitalization and mortality in adults infected with the coronavirus by 30%. This is significantly lower than the initially announced 50% reduction based on incomplete results.

FDA regulators said Merck’s latest information is still under consideration and will present a new assessment of the benefits of the drug to an external panel. The effectiveness of molnupiravir is an important issue when considering whether panel members recommend the drug and for whom.

One of the key questions is whether to limit the use of pregnant women or women of childbearing age.

In a safety review, FDA staff said animal studies suggest that Merck’s drugs can cause birth defects when given at high doses. Regulators said they are considering other precautions, such as a complete ban on the use of molnupiravir during pregnancy and recommending contraceptives to some patients taking pills.

Merck’s medicine uses a new approach to combat COVID-19. It inserts a small error in the genetic code of the coronavirus to prevent the virus from multiplying. Its genetic effects have raised concerns that the drug may cause mutations in the human foetation and spur more virulent strains of the virus.

Another important issue is whether the drug should be provided to vaccinated or previously infected patients with COVID-19. Merck did not study the drug in vaccinated people, but data from a small number of previously infected patients suggested that it provided little benefit. Still, it may be impractical for doctors to screen those patients. Merck’s medications work best when administered within 5 days of the first COVID-19 symptoms, emphasizing the need for immediate treatment.

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