UK authorizes Merck, Ridgeback’s oral COVID-19 medicine Molnupiravir for use on adults

The antiviral Molnupiravir became the first oral treatment for COVID-19 to receive authorization this week, winning approval from the U.K.’s Medicines and Healthcare Products Regulatory Agency for treatment of mild-to-moderate COVID-19 cases in adults.

Specifically, users must have had at least one positive SARS-CoV-2 diagnostic test and possess at least one risk factor for developing severe illness. Further, this approval is for the U.K. alone — other regulatory agencies, such as the U.S. Food and Drug Administration and the European Medicines Agency, are still evaluating the drug’s capabilities.

“The first global authorization of molnupiravir is a major achievement in Merck’s singular legacy of bringing forward breakthrough medicines and vaccines to address the world’s greatest health challenges. In pursuit of Merck’s unwavering mission to save and improve lives, we will continue to move with both rigor and urgency to bring molnupiravir to patients around the world as quickly as possible,” Robert Davis, CEO and president of Merck, said.

Merck developed molnupiravir alongside Ridgeback Biotherapeutics. A planned interim analysis of a Phase 3 trial of the drug showed positive results when an 800 mg dose was taken twice-daily by non-hospitalized, unvaccinated patients.

“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,” Wendy Holman, CEO of Ridgeback Biotherapeutics, said. “It is also gratifying to see the first global authorization occur in the U.K., the very place where we administered molnupiravir to the first brave human volunteer.”

Merck expects to have produced 10 million courses of treatment by the end of 2021 and 20 million courses at a minimum throughout 2022. Within the U.K., it has a deal with the government to supply 480,000 courses, while a separate deal with the United States could provide approximately 1.7 million courses of molnupiravir, pending approval. The treatment will be trademarked as LAGEVRIO, but no trademark has been approved yet for other nations.