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FDA Panel Supports Merck’s Covid Pill

FDA Panel Supports Merck’s Covid Pill
folder_openUnited States access_time5 months ago
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By Staff, Agencies

A panel of expert advisers to the American Food and Drug Administration [FDA] voted on Tuesday to recommend the authorization of Merck’s antiviral pill to treat Covid.

If approved, the drug would be the first at-home treatment for the virus nearly two years into the pandemic.

The authorization would likely be limited to patients with high risks of developing severe diseases, although the exact population would be defined by the FDA, Reuters reported.

Last week, Merck suggested that the drug was significantly less effective than previously thought, citing data that showed a 30 percent reduction of hospitalizations and deaths in the pill’s clinical trial of high-risk individuals.

"Covid-19 is still an emergency situation," said committee member Dr. David Hardy, who voted in support of the pill.

"This is the first opportunity that an oral outpatient medication for mildly symptomatic to moderately symptomatic persons would be available, although I do have questions about its overall longer-term efficacy,” he added.

The vote comes amid fears about the newly discovered omicron variant, sparking border-closures and re-impositions of lockdowns among dozens of countries.

Merck’s oral therapy called molnupiravir targets part of the virus, the RNA polymerase, which was not changed much by mutations in the omicron variant.

The pill - alongside another drug being developed by Pfizer - could become more vital if vaccine-induced and natural immunity are threatened by the latest strain, Reuters suggested.

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