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Merck to seek emergency authorization for oral Covid treatment after ‘compelling results’ in trials

A phase 3 trial of Merck and Ridgeback Biotherapeutics’ oral antiviral treatment molnupiravir showed it reduced the risk of hospitalization or death by around 50% in Covid-19 patients.
Merck plans to seek Emergency Use Authorization in the U.S. and submit marketing applications to other global drug regulators.
If authorized by regulatory bodies, molnupiravir could be the first oral antiviral medicine for Covid-19.

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Merck and Ridgeback Biotherapeutics plan to seek emergency authorization for their oral antiviral treatment for Covid-19, after the medicine showed “compelling results” in clinical trials.

The drug, molnupiravir, reduced the risk of hospitalization or death by around 50% for patients with mild or moderate cases of Covid-19, the companies announced on Friday. Molnupiravir is administered orally and works by inhibiting the replication of Covid-19 inside the body.

An interim analysis of a phase 3 study found that 7.3% of patients treated with molnupiravir were hospitalized within 29 days. Of the patients who received a placebo, 14.1% were hospitalized or died by day 29. No deaths were reported in patients who were given molnupiravir within the 29-day period, while 8 deaths were reported in placebo-treated patients.

All 775 trial participants had laboratory-confirmed symptomatic Covid-19 and were randomly allocated either molnupiravir or a placebo within five days of the start of their symptoms.

Every participant was unvaccinated and had at least one underlying factor that put them at greater risk of developing a more severe case of the virus. The most common risk factors included obesity, being over the age of 60, diabetes and heart disease.

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