NEW YORK (Pakistan Point News / Sputnik - 02nd October, 2021) US drugmaker Merck said on Friday it will seek emergency authorization for its molnupiravir pill for the coronavirus which has reduced by around half the risk of hospitalization or death for patients with mild or moderate cases of COVID-19.
"At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%," Merck said in a news release. "Merck plans to submit an application for Emergency Use Authorization to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide."
If approved, the drug that Merck jointly developed with Ridgeback Biotherapeutics would be the first COVID-19 oral drug greenlighted by the food and Drug Administration.
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 eight deaths were reported in placebo-treated patients.
"With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic," Merck President and Chief Executive Robert M. Davis said.
All 775 trial participants had laboratory-confirmed symptoms of� COVID-19 and molnupiravir or a placebo were randomly administered within five days of symptoms, the Merck statement said.
Adverse events were comparable in the molnupiravir and placebo groups, with around 10% reporting adverse events. Just 1.3% of the molnupiravir group discontinued therapy due to an adverse event � less than the 3.4% of the placebo group who did so.
Participants were 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 age 60 and having diabetes or heart disease.
Molnupiravir's efficacy was not affected by the timing of symptom onset or patients' underlying risk factors, the study showed. It also proved to be consistently effective in treating all variants of Covid, including the widely dominant and highly transmissible delta strain.
The trial was conducted at more than 170 locations, in countries including the United States, Brazil, Italy, Japan, South Africa, Taiwan and Guatemala.
