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US FDA panel slightly supports Merck’s home-based COVID-19 pill by Reuters

© Reuters. File Photo: An experimental COVID-19 treatment called Molnupiravir, developed by Merck & Co Inc and Ridgeback Biotherapeutics LP, was released by Merck & Co Inc and in this dateless distribution photo obtained by Reuters on October 26, 2021. You can see it.

By Michael Erman and Manas Mishra

(Reuters)-On Tuesday, a committee of expert advisors from the US Food and Drug Administration voted narrowly to recommend that authorities approve Merck’s antivirals to treat COVID-19.

If the FDA approves the drug, it will be the first home treatment nearly two years after the pandemic occurred. The exact population is defined by the authorities, but approval may be limited to patients at high risk of developing severe illness.

Last week, Merck released data suggesting that the drug’s efficacy was significantly lower than previously thought, reducing hospitalization and mortality in clinical trials for high-risk individuals by about 30%.

“COVID-19 is still an emergency,” said Dr. David Hardy, a member of the committee who voted in favor. “We need something like this. There are doubts about its overall long-term efficacy, but this is the first opportunity for oral outpatients to be available for people with mild to moderate symptomatic symptoms. is.”

The vote was made because concerns about the new Omicron variant have shaken financial markets and raised concerns about the strength of the global economy’s recovery as the world continues to fight the coronavirus pandemic.

Developed by Ridgeback Biotherapeutics, Merck’s oral therapy, molnupiravir, targets a portion of the virus called RNA polymerase that is not significantly altered by mutations in the Omicron variant.Pills-and potentially more promising drugs being developed by Pfizer -It can be even more important if the vaccine-induced innate immunity is threatened by the mutant.

“Looking at the sequence of RNA polymerase, we can predict that the sequence of the Omicron mutant is not so different from all these other mutants, so it should be equally active,” said Merck scientist Dalia Hazda. States as follows. interview.

Paxlovid, a rival pill from Pfizer Inc (NYSE :), showed that hospitalization and mortality were reduced by 89% in its clinical trials. The FDA may consider the drug in the coming months.

The FDA’s Antimicrobial Advisory Board voted 13-10 to discuss with authorities not only safety concerns about the possibility of birth defects, but also concerns that the drug could mutate the virus. Recommended for approval. Both FDA staff scientists and Merck suggest that the drug should not be recommended during pregnancy.

Some members said they persuaded them to vote in favor of recommending approval because of the reduced COVID-related deaths among those who received the drug in the trial. Only one patient died in the molnupiravir group, compared to nine in the placebo group.

Earlier this month, the UK conditionally approved Molnupiravir, branded as La vrio.

Merck plans to provide 10 million courses by the end of this year, with at least 20 million courses planned to be manufactured in 2022.

The US government has contracted to buy as many as 5 million courses of medicine at a price of $ 700 per course. By comparison, the United States paid a dose of approximately $ 20 for a two-dose Pfizer / BioNTech vaccine supply.

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US FDA panel slightly supports Merck’s home-based COVID-19 pill by Reuters US FDA panel slightly supports Merck’s home-based COVID-19 pill by Reuters

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