COVID-19: Merck Seeks FDA Emergency Use Authorisation for Antiviral Pill

• Merck seeks FDA emergency use authorization for antiviral pill treatment molnupiravir for COVID-19.
• Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021.

Ekohotblog reports that pharmaceutical giant, Merck, known as MSD outside the US and Canada, and Ridgeback Biotherapeutics, said Monday, October 11, that it is seeking emergency use permission from the US Food and Drug Administration, FDA, for its investigational antiviral Covid-19 therapy, molnupiravir.

If approved, the medication, developed by Merck and Ridgeback Biotherapeutics, would be the first oral antiviral therapy for Covid-19. It is available in capsule form.

Merck stated that it is requesting permission to use the capsules to treat sick individuals who are at risk of developing severe Covid-19 illness or requiring hospitalization.

Its application is based on a trial that was halted in the middle because the medicine was performing so effectively in more than 700 patients who were randomly allocated to receive either molnupiravir or a placebo.

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“At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%; 7.3% of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 14.1% of placebo-treated patients,” the company said in a statement.

“Through Day 29, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo.” None of the volunteers in the trial had been vaccinated.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Merck CEO and President Robert Davis said in the statement.

Data from the trial has not yet been peer-reviewed or published.

“Merck has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022,” the company said.

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It has already sold the US government 1.7 million treatment courses. The business stated that it will offer tiered pricing to ensure global access and will collaborate with generic medication makers to accelerate availability to low- and middle-income nations.

Dr. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, termed the study results “extremely positive” during a White House Covid-19 briefing last week, but warned the medication has to be closely monitored by the FDA.

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“It is very important that this now must go through the usual process of careful examination of the data by the Food and Drug Administration both for effectiveness, but also for safety, because whenever you introduce a new compound, safety is very important,” Fauci said, noting that vaccines remain “our best tools against Covid-19” by preventing infection and illness, rather than treating it.