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Merck to seek emergency authorization for oral Covid treatment - Printable Version

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Merck to seek emergency authorization for oral Covid treatment - superadmin - 10-01-2021

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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