Merck & Co Inc. is planning to seek emergency-use authorization for its Covid-19 antiviral pill molnupiravir from the US drug authorities as early as possible, the multinational company said on Friday.
As per a statement, the firm also plans to submit applications to regulators in other countries.
Interim analysis of late-stage trials has shown that molnupiravir reduced the risk of hospitalization or death by 50%. The findings can give doctors another potent virus-fighting tool.
“We couldn’t be more thrilled with the results,” Chief Executive Officer Rob Davis said.
“You don’t have to go to the hospital, you don’t have to go to a center to have it infused. It’s a pill you can take at home,” he added.
Earlier this week, Merck presented other data from early-stage research showing that molnupiravir appears to inhibit several major variants of the coronavirus, including the highly contagious delta strain.
Findings of study
Merck said about 7% of patients on molnupiravir went on to be hospitalized or die, versus 14% of those on a placebo. None of those taking molnupiravir died, compared with eight deaths among the placebo group.
The findings came out of a previously planned analysis of 775 patients who had been in the clinical trial since at least early August.
Merck had planned to enroll 1,550 patients in the trial, with around 90% already signed up, according to a release. Patients who were taking a placebo will have the opportunity to start on molnupiravir, Davis said.
The company said that it expects to produce 10 million courses of treatment by year-end, with more expected to be produced in 2022.
The study has currently been halted.
The continuing phase 3 trial had been expected to conclude in November. But the decision to stop the research was made at the recommendation of an independent committee and in collaboration with the FDA, Davis said.
Molnupiravir is being developed by Merck in collaboration with Ridgeback Biotherapeutics LP for use in nonhospitalized Covid-19 patients who have had symptoms for five or fewer days and are at risk for a severe infection.
If authorized, it could become an important new tool for the treatment of Covid-19. While drugs known as monoclonal antibodies are available to stave off more severe infections, they can be difficult to administer, and demand for them has surged during the recent spike in virus cases fueled by the delta variant.
Adding molnupiravir would give doctors a much simpler option to treat sick patients that could keep them from filling strained hospitals. Delta’s rise has taxed health systems across the country, especially in areas where vaccination rates are lower than average.
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