- Merck and partner Ridgeback Biotherapeutics have won U.K. authorization to sell the first pill for COVID-19, a major milestone and a decision that could be soon repeated as regulators in the U.S. and elsewhere review the drug.
- On Thursday, U.K. regulators cleared molnupiravir for people with mild-to-moderate cases of COVID-19 who are at greater risk of developing severe disease because of a risk factor such as obesity or heart disease. They recommended the drug be used as soon as possible after a positive test and within five days of the onset of symptoms.
- Study results from Merck showed the drug, to be sold under the trade name Lagevrio, can cut the risk of hospitalization and death in half, while offering an easier option than infusions of monoclonal antibodies. A pill to treat COVID-19 that can be taken at home is a "gamechanger," U.K. Health and Social Care Secretary Sajid Javid said in a statement announcing the authorization.
U.K. regulators have once again moved faster than the Food and Drug Administration to approve a new medicine for COVID-19. The UK's Medicines and Healthcare products Regulatory Agency, or MHRA, also approved Pfizer and BioNTech's vaccine for COVID-19 ahead of the FDA in December 2020.
Applications for approval of molnupiravir are under review at the FDA and the European Medicines Agency, and Merck said it's actively working on regulatory submissions for other countries around the world.
Merck began large-scale manufacturing of the drug well before approval to prepare for expected high demand. The company claims it can produce 10 million courses of treatment by the end of this year and at least 20 million next year.
The U.S. has locked up 1.7 million of those courses as part of a $1.2 billion purchase agreement in June. Merck has made other pre-approval purchasing deals as well, including one to supply 480,000 courses to the U.K. government. The company has also promised to ensure access to lower-income countries and signed voluntary licensing agreements to help make that happen.
Merck expects significant demand for the pill, with executives recently forecasting sales of $5 billion to $7 billion
through the end of next year.