The U.S. FDA panel is backing Mercury’s COVID-19 pill at Merck’s home

By Michael Erman and Manas Mishra

(Reuters) – Experts from the U.S. Food and Drug Administration voted on Tuesday to recommend that the agency authorize Merck & Co’s anti-virus pill to treat COVID-19.

If the FDA approves the drug, it would be the first home treatment for the virus nearly two years after the pandemic began. It is likely that permission would be limited to patients at high risk of developing a serious illness, although the exact population will be determined by the agency.

Data released by Merck last week suggested that the drug was much more effective than expected, and reduced hospitalizations and deaths in the clinical trial of high-risk people by about 30%.

“COVID-19 is still a state of emergency,” said Dr. David Hardy, a member of the committee, who voted yes. “Something like this is needed. This is an oral outpatient medication that will be available to a mild or moderate symptomatic person, even if I have doubts about the overall effectiveness in the longer term.”

Voting fears that the new Omicron variant has shaken financial markets and raised concerns about the strength of the global economic recovery as the world continues to face the coronavirus pandemic.

Merck’s oral therapy called molnupiravir, developed with Ridgeback Biotherapeutics, targets a part of the RNA polymerase virus that has not changed much as a result of mutations in the Omicron variant. The pill – and one that is developing a potentially more promising drug Pfizer – may be even more important if it is caused by vaccine-induced and natural immunity variants.

“If you look at the sequence of RNA polymerase, the sequence of the Omicron variant is not very different from all these other variants, so you would predict that it should be equally active,” said Daria Hazuda, a Merck scientist. conversation.

Opponents of Pfizer Inc’s (NYSE:) Paxlovid pill showed an 89% reduction in hospitalizations and deaths in its clinical trial. The FDA may consider the drug in the coming months.

The FDA’s Antimicrobial Drug Advisory Committee voted 13-10 to recommend the drug to the agency after discussing concerns that the drug could cause the virus to change, as well as safety concerns about the potential for birth defects. FDA staff scientists and Merck have suggested that the drug should not be recommended during pregnancy.

Several members said the fact that the reduction in the number of deaths associated with COVID in people receiving the drug in the test convinced them to vote in favor of recommending the permit. Only one patient in the Molnupiravir arm died, nine from the placebo group.

The United Kingdom conditionally approved molnupiravir, under the name Lagevrio, earlier this month.

Merck expects to produce 10 million courses of treatment by the end of this year, with at least 20 million to be manufactured by 2022.

The U.S. government has a contract to buy 5 million courses of the drug at a price of $ 700 per course. In comparison, the US paid about $ 20 for the supply of two doses of the Pfizer / BioNTech vaccine.