What is Molnupiravir? First Oral COVID Treatment Could Be Issued By Year's End

Pharmaceutical company Merck and Florida-based Ridgeback Biotherapeutics announced Friday that they plan to seek emergency approval for an oral antiviral treatment for COVID-19.

If authorized by the Food and Drug Administration (FDA), the drug, molnupiravir, could be the first oral antiviral treatment for patients with COVID-19. Merck said it planned to seek emergency use authorization in the U.S. as soon as possible and added that it will also be submitting applications for the drug to "regulatory agencies worldwide."

The companies said that during a phase 3 trial, molnupiravir "significantly reduced the risk of hospitalization or death" in at-risk patients with mild or moderate cases of COVID-19.

The companies said that an interim analysis found that molnupiravir reduced the risk of hospitalization or death by approximately 50%.

According to the press release jointly issued by the two companies, "7.3 percent of patients who received molnupiravir were either hospitalized or died through Day 29 following randomization (28/385), compared with 14.1 percent of placebo-treated patients (53/377)," the companies said.

The release added that no deaths were reported in patients treated with the new drug. In comparison, eight patients who received placebos died of COVID-19.

In a statement, Robert M. Davis, the chief executive officer and president of Merck, said that the company "will continue to work with regulatory agencies on our applications and do everything we can to bring molnupiravir to patients as quickly as possible."

Wendy Holman, the chief executive officer of Ridgeback Biotherapeutics, said that company hopes molnupiravir, if authorized, "can make a profound impact in controlling the pandemic."

"With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with COVID-19 out of the hospital are critically needed," Holman said in a statement.

Merck said it expects to produce 10 million doses of molnupiravir by the end of the year, and more in 2022. It has also entered into a procurement agreement with the U.S., to provide 1.7 million courses of molnupiravir treatment to the government, pending approval or emergency authorization of the drug.

The company also says that it has "entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments." It added that it plans to implement a "tiered pricing approach based on World Bank country income criteria to reflect countries' relative ability to finance their health response to the pandemic."

Update - 10/1/21 - 9:40 AM ET - This story has been updated wth additional information.