Merck asks FDA for emergency approval of Covid pill

Merck said monday that he had filed an application with the Food and Drug Administration to authorize what would be the first antiviral...

Merck said monday that he had filed an application with the Food and Drug Administration to authorize what would be the first antiviral pill to treat Covid.

Authorization for the drug, molnupiravir, would be an important step in the fight against the coronavirus, experts said, as a convenient and relatively inexpensive treatment could reach many more high-risk people with Covid disease than the bulky antibody treatments currently in use.

The Biden administration is preparing for an authorization that could arrive in a few weeks; the pill would likely be allocated to states, as was the case with vaccines. States could then distribute the pills as they wish, for example in pharmacies or doctor’s offices, senior administration officials said.

If the pill gets cleared, tens of millions of Americans will most likely be eligible to take it if they fall ill with Covid – far more than the offer could cover, at least initially. The federal government has placed an advance order for enough pills for 1.7 million Americans, at a price of about $ 700 per patient. That’s about a third of the price the government pays for monoclonal antibody treatments, which are typically given by intravenous infusion.

Merck, which is developing the pill with Ridgeback Biotherapeutics of Miami, hopes to be able to produce enough pills for 10 million people by the end of this year. Governments have ran to lock supplies since strong clinical trial results were released this month; Australia, Malaysia, Singapore and South Korea have all announced deals.

An antiviral pill in development by Pfizer and another by Atea Pharmaceuticals-Roche will report study results in the coming months and, if effective, could increase supply.

The pill from Merck is intended to be taken at home as four capsules twice a day for five days, for a total of 40 pills. This hospitalizations and deaths halved in a clinical trial that recruited unvaccinated adults who had started showing symptoms of Covid within the previous five days and were at high risk for poor disease outcomes.

Merck said it was seeking permission to administer its pill only to high-risk adults, who in the clinical trial were most often people over the age of 60 or younger with obesity, diabetes or cardiac disease.

It was not clear whether the treatment would be available to those vaccinated, who were not eligible for the clinical trial. A spokesperson for the company said it would be up to the FDA to decide.

Originally tested for the flu, the drug works by preventing the coronavirus from replicating by inserting errors into its genetic code.

This mechanism is likely to render a high-risk group, pregnant people, ineligible to receive the pills if they are allowed, for fear that the drug will cause mutations that could lead to birth defects. In the clinical trial, volunteers had to agree to refrain from unprotected sex for four days after they finished taking the pills, and some women of childbearing age had to have a negative pregnancy test to enroll in the pills. ‘study.

Sheryl Gay Stolberg contributed reports.

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Newsrust - US Top News: Merck asks FDA for emergency approval of Covid pill
Merck asks FDA for emergency approval of Covid pill
Newsrust - US Top News
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