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Merck (MRK) Seeks Emergency Nod for Oral Antiviral COVID-19 Pill

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Merck & Co., Inc. MRK, along with partner Ridgeback Biotherapeutics, announced that they have filed an application seeking Emergency Use Authorization (“EUA”) for investigational oral antiviral medicine, molnupiravir, for the treatment of mild-to-moderate COVID-19 in adults who are at risk of progressing to severe COVID-19 and/or hospitalization.

The application was based on positive data from the interim analysis of the phase III MOVe-OUT study that evaluated molnupiravir in the given patient population. Data from the interim analysis showed that the medicine reduced the risk of hospitalization or death by approximately 50%. The interim data also showed that 7.3% of patients treated with molnupiravir were hospitalized or died through day 29, versus 14.1% of placebo-treated patients.

There was no death reported in patients treated with molnupiravir versus eight deaths reported in patients treated with placebo.

If authorized by the FDA, molnupiravir would become the first oral antiviral medicine for the treatment of COVID-19. The processes for applying for emergency use of molnupiravir, to other regulatory authorities worldwide, are currently underway.

Merck has a deal with the U.S. government to supply approximately 1.7 million courses of molnupiravir, once it gets the EUA from the FDA. It has been producing the pills at risk and can produce 10 million courses of treatment by the end of 2021.

We note that currently available COVID-19 medicines require access to a healthcare facility or can be given to patients with severe disease. Oral antiviral pills can be taken at home by patients who are moderately infected without the need to go to a hospital, and can thus reach a much larger number of people.

Few other companies like Atea Pharmaceuticals, Inc. AVIR, Roche RHHBY and Pfizer PFE are also developing antiviral pills for the treatment of COVID-19.

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