Since the start of the pandemic, even as vaccines and monoclonal antibodies made their way onto the market, an authorized oral antiviral therapy evaded the global response. Not anymore.
Merck & Co. and Ridgeback Therapeutics' molnupiravir has scored its first authorization in the world. U.K. Regulators signed off on the oral antiviral for adults who've had a positive COVID-19 test and who have at least one risk factor.
The country's Medicines and Healthcare products Regulatory Agency green-lit the drug based on an interim analysis from the phase 3 Move-Out trial. The study showed the med, given at 800 mg twice daily, reduced the risk of hospitalization or death by about 50% in adult patients who were not hospitalized or vaccinated. For the study, the mild-to-moderate patients had symptom onset within five days of randomization, and they also had at least one risk factor.
Ahead of the authorization, the U.K. government inked a deal to purchase 480,000 courses from Merck. In the U.K., the drug will be marketed as Lagevrio.
Meanwhile, Merck has submitted the drug to the FDA, and the European Medicines Agency has started a rolling review.
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Since Merck touted its phase 3 study results, the company has been busy in supply talks with governments around the world. Over the summer, the U.S. government agreed to buy 1.7 million doses for $1.2 billion.