Merck’s and Ridgeback’s Oral Treatment for COVID-19 Gets Its First Regulatory Approval

Merck’s and Ridgeback Biotherapeutics’ oral COVID-19 medication got its first green light from a regulatory body this week when the UK approved it, making it the first oral antiviral medicine authorized for the treatment of COVID-19. The companies still await authorization from the FDA, which could come early next month.

The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has authorized molnupiravir for the treatment of mild-to-moderate COVID-19 in adults who have at least one risk factor for developing severe illness.

The authorization triggers a procurement agreement under which Merck will supply 480,000 courses of the therapy to the UK government. And Merck has a separate agreement to supply approximately 1.7 million courses of molnupiravir to the U.S. government, once the FDA issues an Emergency Use Authorization (EUA) or approval.

The European Medicines Agency (EMA) has initiated a rolling review of the company’s marketing authorization application.

Merck and Ridgeback filed their application with the FDA seeking an EUA for the pill on Oct. 11. The application is still under review, and an FDA advisory committee is set to consider molnupiravir on Nov. 30, offering its recommendation on the drug.

The companies announced the results of a phase 3 trial in early October, which showed that molnupiravir cut the risk of hospitalization or death by 50 percent in COVID-19 patients with mild or moderate infections (DID, Oct. 4).

Late in October, Merck announced that it had struck a licensing pact with the Medicines Patent Pool (MPP), a United Nations-supported public health organization serving the developing world, to expand access to molnupiravir (DID, Oct. 28).

The precedent-setting agreement marks the first licensing deal for a COVID-19 treatment inked with the MPP, which has previously distributed HIV, tuberculosis and hepatitis C drugs to poorer nations. Under the deal, 105 low- and middle-income countries will gain access to the treatment, following authorization from the World Health Organization and/or national regulators.

Merck said it has been producing molnupiravir at risk and expects to produce 10 million courses of treatment by the end of 2021, with at least 20 million courses to be produced in 2022.

The UK’s approval of molnupiravir this week puts the drug far ahead of those of competitors who are toiling away on oral COVID-19 medicines.

That includes Pfizer, which began a phase 2/3 study on a novel oral COVID-19 antiviral candidate — a protease inhibitor — administered with a low dose of ritonavir (an antiviral focused on HIV infection) for prevention of illness in adults living in the same household as someone with COVID-19 (DID, Sept. 28).

It also includes Gilead Sciences, which is developing oral treatments for nonhospitalized patients with COVID-19 and hopes to file investigational new drug applications with the FDA by early next year (DID, Sept. 24). — Suz Redfearn