Merck Seeks U.S. Emergency Approval For Antiviral Covid Pill

Merck announced Monday that it requested emergency approval from the U.S. regulators to approve an antiviral medication to treat Covid-19. This is the first treatment of its type, according to the company. It also provides an important weapon against coronavirus in non-hospital settings.

Merck seeks emergency approval for its oral antiviral molnupiravir. Merck

The Key Facts

Merck stated that it has applied for emergency authorization from the U.S. Food and Drug Administration to use molnupiravir as an oral antiviral medication for patients with recently diagnosed severe illnesses. Merck stated that it is seeking authorization for the use of the pill to treat patients with mild-to moderate Covid-19, who are at high risk of serious illness or hospitalization. Merck stopped its late-stage study in October on the basis of promising interim results. This was a decision that the FDA approved and had been recommended to them by an independent panel of experts who were monitoring the trial. Molnupiravir, if approved, will be the first antiviral drug to treat Covid-19. All other antivirals that are authorized in the U.S. must either be administered intravenously or injected.

Important Background

Covid-19 treatments can be expensive so they are not recommended for patients in hospitals. Patients with no serious illness are not recommended to use the Covid-19 treatments outside of hospitals. Monoclonal antibody treatment are rare and must be administered intravenously in hospitals. Pills could prove to be a gamechanger in a pandemic and ease the burden on hospitals that are overwhelmed. Pills are easy to make, cheaper to produce and easier to distribute. They can also be taken at home with no medical supervision.

What to Watch

Other oral antivirals are in advanced development and could be used against Covid-19. Pfizer, a Swiss pharmaceutical giant Roche and Boston-based Atea Pharmaceuticals are testing one to prevent or treat Covid-19. All three companies are expecting trial results to be available later in the year, which, if positive, could form the basis for an emergency use application.

Big Number

1.7 Million. This is how many five-day molnupiravir treatment courses the U.S. has purchased. Scott Gottlieb, former FDA commissioner and Pfizer board Member, said that this is insufficient. He pointed to the 50-80M therapy courses held back in case of an epidemic.

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What is the best time to get a pill for covid? Here Are Three Antiviral Drugs Being Tested (Forbes)

Merck: Its Antiviral Pill Reduces Covid Hospitalizations and Deaths by Half (Forbes).

Antiviral pill: Are we close to developing a drug that can treat Covid? (Financial Times)

The COVID drug hunt reveals how antiviral pill Molnupiravir jumped ahead (Nature).

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