Merck Seeks FDA Authorization for First COVID-19 Pill

The pharmaceutical company Merck on Monday asked the U.S. Food and Drug Administration (FDA) to grant emergency use authorization for what would be the first pill to treat COVID-19.

The investigational oral antiviral medicine molnupiravir is designed to treat mild to moderate COVID-19 in adults who are at risk of progression to severe COVID-19 and hospitalization.

All other treatments approved by the FDA so far require an IV or injection. This pill, which can be taken at home shortly after diagnosis with COVID-19, has the potential to relieve overburdened hospital systems by helping people return to health without intensive medical attention. A course of treatment is 40 pills taken eight pills daily for five days, starting within five days of the onset of symptoms, according to the Wall Street Journal.

Interim analysis from a phase 3 clinical trial involving 775 participants revealed that molnupiravir reduced the risk of hospitalization or death by about 50 percent. Just over 7 percent of patients who received molnupiravir were hospitalized through day 29 of the trial, compared with 14.1 percent in the placebo group who were hospitalized or died.

While eight people who received the placebo died during the trial, there were no deaths at all among those receiving molnupiravir. At the study's start, all patients were required to have at least one risk factor associated with poor disease outcome, such as hypertension, diabetes, or obesity.

“We are very encouraged by the results from the interim analysis and hope molnupiravir, if authorized for use, can make a profound impact in controlling the pandemic,” said Wendy Holman, the chief executive officer of Ridgeback Biotherapeutics, a biotechnology company that partnered with Merck in the development of the new medication, in a statement.

Dean Y. Li, MD, PhD, the president of Merck Research Laboratories, said that the findings suggest molnupiravir is even more effective against SARS-CoV-2 than Tamiflu is against influenza.

When molnupiravir will become available to the general public is still unknown, but William Schaffner, MD, an infectious-disease specialist and a professor of preventive medicine and health policy at Vanderbilt University School of Medicine in Nashville, expects the FDA may grant emergency authorization in the next 8 to 10 weeks.

“The drug hasn’t been approved yet, but this could be a very important new therapy for early COVID disease,” says Dr. Schaffner. “Pills are so much easier to administer than the current monoclonal antibodies, which require injections and intravenous infusions.”

Robert Shafer, MD, a professor of medicine at Stanford University who specializes in the treatment of infectious diseases, points out that top-line data on monoclonal antibodies show so far that they are more effective at preventing hospitalization. Phase 3 results from clinical trials of remdesivir (brand name Veklury) indicated that the monoclonal antibody was 87 percent effective at reducing hospitalizations in high-risk patients who were diagnosed early.

“I think the recommendations for high-risk individuals are likely to still be monoclonal antibodies, but there will be a lot of careful looking into the data in the next few weeks, especially as this goes to the FDA for emergency use authorization to try to figure out who should get monoclonal antibodies and who can just get oral molnupiravir,” says Dr. Shafer.

In expectation of regulatory authorization, Merck aims to produce 10 million courses of treatment by the end of 2021, with more courses expected to be produced in 2022.

The Associated Press noted that the U.S. government has agreed to buy enough of the pills to treat 1.7 million people, at a price of roughly $700 for each course of treatment. In an interview with the news service, Nicholas Kartsonis, a senior vice president with Merck’s infectious disease unit, said that the $700 figure does not represent the final price for the medication, adding that Merck wants to “make this drug as accessible to as many people around the world as we can.”