US health regulators authorize a second antiviral pill against COVID-19 by Merck

Dec 23, 2021: U.S. health regulators have approved another antiviral pill against COVID-19, another easy-to-use drug to combat the rising tide of Omicron variant.

The U.S. Food and Drug Administration on Thursday approved Merck’s Molnupirevir. The approval comes a day after the agency approved a similar drug from Pfizer. That pill, Paxlovid, will probably become the first treatment against the virus, thanks to its superior benefits and mild side effects.

Merck’s drug has been shown to reduce hospital admissions and deaths by approximately 30% in clinical trials of high-risk individuals in the early stages of the disease.

The FDA has approved oral medication to treat mild to moderate COVID-19 in adults who are at risk of serious illness, and for whom alternative corona virus treatment is not accessible or medically appropriate. Molnupiravir’s ability to deal with severe COVID-19 is much lower than initially announced and the drug label will warn of safety issues, including the possibility of birth defects.

The Pfizer tablet works differently and does not carry the same risks. In addition, Pfizer’s drug was about three times more effective in testing than Merck, which reduced hospital admissions and deaths by approximately 90% in high-risk patients.

However, both Merck and Pfizer tablets can be promising tools for those who are sick with COVID-19, especially in the face of the rapidly expanding Omicron variant, which is now dominant in the United States and beyond.

Such antiviral pills, including Merck’s, are expected to be effective against Omicron because they do not target the protein spikes where most of the variant’s mutations reside.

Merck’s drug is not authorised for use in patients younger than 18 because molnupiravir may affect bone and cartilage growth, the FDA said. Pfizer’s drug was authorised on Wednesday for people aged 12 and older.

The US government’s contract for 10 million courses of the Pfizer drug at a price of $530 per course compares with the deal with Merck for as many as 5 million courses of molnupiravir at a price of $700 per course. Both treatments will be free to patients in the US.

Merck’s senior vice president for clinical research, Dr Nick Kartsonis, said the company’s scientists are still studying the drug and they hope to eventually get it approved for use in children.

The restrictions on molnupiravir were expected after an FDA advisory panel only narrowly endorsed the drug last month, warning that its use would have to be strictly tailored to patients who can benefit the most.

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