Merck’s Covid pill protects the limited support of the US regulatory body

U.S. government advisers have strongly suggested that doctors be allowed to prescribe Merck antiretroviral drugs to high-risk patients, and initiate a process to approve the new Covid-19 treatment amid concerns over Omicron diversity and the recent increase in morbidity.

Health experts from the U.S. Food and Drug Administration who voted between 13 and 10 Tuesday to give a green light to molnupiravir drug, have been shown to be able to reduce the risk of serious illness and death from Covid-19 in non-vaccinated people. about one-third.

However, consultants have stated that easy to provide support should be recommended for high-risk patients over the age of 18 with mild symptoms. The committee recommended that it be banned from using pregnant women out of concern for its consequences.

U.S. officials should not follow the Drug Advisory Committee’s recommendation, but many experts expect the FDA to immediately approve the drug out of concern. Omicron, a new species of coronavirus that is rapidly spreading in southern Africa.

Authorities in the UK and EU, where countries are battling new diseases before winter, given permission to use molnupiravir abruptly this month.

For several hours Tuesday, members of the FDA committee debated whether the benefits offered by the drug outweighed the potential risks.

Last week, Merck said the treatment was less effective than he thought.

An earlier review of a large medical study found that it reduced hospital stay by about 50 percent compared to placebo – prompting Merck to suspend the study and request emergency clearance. But the figure has dropped to about 30 percent by the end of the experiment.

“I voted but this was a very difficult decision,” said Michael Green, a member of the advisory committee and professor at the University of Pittsburgh.

The only Covid drugs approved outside hospitals in the US are monoclonal antibodies manufactured by Regeneron, Eli Lilly and GlaxoSmithKline, which are usually delivered via veins.

If approved by the FDA, doctors may prescribe a five-day course of Merck antiviral tablets for home use. However, experts have found that care should be given within a few days of taking Covid to work.

Earlier Tuesday, Regeneron warned that preliminary tests said his treatment would be limited less effective among people with Omicron virus. Moderna, a vaccine maker, too he predicted that existing jabs may not be effective in combating the new species.

Green said he voted to approve Merck’s treatment because of “a lack of alternative support for high-risk individuals, possibly including the potential for loss and power of monoclonals in color outages”.

Fear that vaccines and current drugs have successfully addressed these differences has led some health experts to predict that pills such as Merck will play a key role in treating Omicron’s disease.

Pfizer he has asked again to approve the sudden use of antiviral pills, which reduced hospitalization and mortality by about 90 percent in large-scale high-risk tests with Covid.

Unlike vaccines with monoclonal antibodies, Merck tablets do not fight off viral proteins. Instead, they try to manipulate the virus by using the wrong binding, which results in a change that results in a weakened chain. Pfizer pill inhibits the enzyme that coronavirus has to replicate.