Merck to request emergency approval for COVID-19 antiviral pill

Merck plans to request emergency approval for an experimental oral COVID-19 antiviral drug, molnupiravir, after a late-stage trial indicated an approximate 50% risk reduction for hospitalization or death among patients with mild to moderate COVID-19.

An interim analysis, stemming from the Phase 3 MOVe-OUT trial, indicated 7.3% of patients who received molnupiravir were hospitalized or had died about a month later, compared with 14.1% of patients receiving a placebo. The company also reported no deaths in the treatment group, versus eight deaths in the placebo group.

"Merck plans to submit an application for Emergency Use Authorization (EUA) to the U.S. FDA as soon as possible based on these findings and plans to submit marketing applications to other regulatory bodies worldwide," the company said Friday.

The company also noted that recruitment for the study was halted early given the positive findings, with over 90% of the targeted sample size already reached, and after consultation with the FDA and an independent data monitoring committee.

Molnupiravir works by targeting the enzyme needed for the virus to make copies of itself and introduces errors into the virus’s genetic code. This curtails the patient’s viral load, shortening the duration of the illness and mitigating serious symptoms.

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"More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world," Robert M. Davis, Merck CEO and president, said in the release, adding in part, "With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic."

According to Timothy Sheahan, a virologist at the University of North Carolina-Chapel Hill, who helped pioneer these therapies, "Oral antivirals have the potential to not only curtail the duration of one’s COVID-19 syndrome but also have the potential to limit transmission to people in your household if you are sick." 

Wendy Holman, CEO of Ridgeback Biotherapeutics, noted a critical need for at-home antiviral treatments to keep COVID-infected individuals out of the hospital, and anticipated molnupiravir's potential to have "profound impact in controlling the pandemic," should the drug become authorized for use.

Molnupiravir would be used after diagnosis and is thus not a replacement for vaccination, but it can help reduce transmission.

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At last week’s annual meeting of infectious disease organizations, Merck presented an analysis of its findings on molnupiravir. 

In a trial earlier this year, the company enrolled nonhospitalized, COVID-19 patients who have had symptoms for more than five days and were at risk for COVID-19 complications. When treated with molnupiravir, none of the patients tested positive after five days, while 24% of placebo patients did.

Merck aims to produce 10 million courses of treatment by the end of the year, with more supply expected in 2022. Upon emergency authorization or approval, the company will supply the U.S. government with 1.7 million courses of molnupiravir, and is in talks with other governments as well, a company announcement reads.

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Pfizer is working on its own oral antiviral, as is Roche and Atea Pharmaceuticals.