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FDA To Decide On Merck's Covid-19 Pill


RTTNews | Nov 30, 2021 02:07PM EST

14:06 Tuesday, November 30, 2021 (RTTNews.com) - An advisory panel to the Food and Drug Administration is meeting on Tuesday to decide on recommending whether the regulator should grant emergency use authorization to Merck's (MRK) experimental pill, molnupiravir, to treat coronavirus. The FDA's Antimicrobial Drugs Advisory Committee members will take a closer look at Merck's data before giving their vote on the authorization. The FDA is not bound to follow the committee's recommendations, but in most cases, it does.

In October this year, the company had asked the FDA to give clearance to the drug, which could be given to adults who have mild or not-so-severe Covid, for whom the disease can turn serious and they may need to be hospitalized. If the pill is given authorization, then it would be the first-antiviral pills to be given since the basket coming clean.

Last week, Merck had shown papers, which showed that the pills reduce the high rate of hospitalization and death among people by at least some percent.

According to reports, doctors will still mostly demand monoclonal antibodies and the new form of treatment is useful for those who require a quick getaway.

The benefit of being able to prescribe something in the middle of the night on weekends, and have a patient just go to their local pharmacy to pick up the pills cannot be overstated, the company said. Uptake is likely to be better for a pill than monoclonal antibody treatments, which require an infusion.

Earlier, the demand for Merck's drug could be more than the supply as the Biden administration talked about ordering 3.1 million courses of purchase as well as $.2.2 billion from the company.

Demand for the drug could also be affected by Pfizer's oral antiviral treatment which could bring down the severity of the Covid-19 infection. The company said that no major safety issues were identified in the clinical trial data for its pill, even though the drug increases the pace of change of SARS-CoV-2 spike protein evolution.

Read the original article on RTTNews ( https://www.rttnews.com/3245783/fda-to-decide-on-merck-s-covid-19-pill.aspx)

For comments and feedback: contact editorial@rttnews.com

Copyright(c) 2021 RTTNews.com All Rights Reserved






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