Merck’s COVID-19 Treatment Receives First Authorization in UK
The UK based its decision on the Phase 3 trial that found Merck’s COVID-19 treatment reduced the risk of hospitalization or death by nearly 50% in COVID-19 patients.
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By - Merck and Ridgeback Biotherapeutics recently announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) authorized their COVID-19 treatment for adults.
The UK’s authorization of molnupiravir, known as Lagevrio in the UK, is the first in the world to treat mild-to-moderate coronavirus in adults who have at least one risk factor for developing severe illness.
“This is a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges,” Robert M. Davis, chief executive officer and president of Merck, said in the announcement.
“We will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” Davis continued.
The MHRA based its decision on positive results from the Phase 3 MOVe-OUT clinical trial, which evaluated molnupiravir 80 milligrams twice-daily in non-hospitalized, unvaccinated, COVID-19-positive adult patients.
In the trial, molnupiravir reduced the risk of hospitalization or death by nearly 50 percent. And 7.3 percent of patients who received the treatment were either hospitalized or died through Day 29, compared with 14.1 percent of placebo-treated patients.
Researchers reported no deaths in the molnupiravir group, while there were eight deaths in the placebo group.
Currently, Merck’s FDA emergency use authorization of molnupiravir is under review. And the European Medicines Agency (EMA) recently initiated a rolling review of the company’s marketing authorization application.
Merck stated that it is actively working to submit applications to other regulatory agencies globally.
“It is gratifying to reach this milestone and show that the extraordinary effort of our collaborators, patients, physicians and team and the personal sacrifices made have now achieved that important goal,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics.
“It is also gratifying to see the first global authorization occur in the UK, the very place where we administered molnupiravir to the first brave human volunteer,” Holman concluded.
