Long-awaited “COVID Pill” may soon be available in US

Drugmaker Merck announced Monday it has taken a major step that could lead to the first FDA-approved COVID-19 pill. Currently, all other FDA-backed treatments against the disease require an IV or injection. Merck said in a press release it had applied for emergency use authorization for their antiviral pill, called molnupiravir.

According to the press release, the application followed a study on the effectiveness of the pill in preventing COVID-19-related hospitalizations and deaths. That study found the pill cut hospitalizations and deaths by 50 percent. 29 days into the study, there had been no COVID-19 deaths among people who took the pill, compared to eight deaths among people who took a placebo. In addition, side effects were similar between patients who got the drug and those in a testing group who received a dummy pill.

“The extraordinary impact of this pandemic demands that we move with unprecedented urgency, and that is what our teams have done by submitting this application for molnupiravir to the FDA within 10 days of receiving the data,” Merck CEO/President Robert M. Davis said. “We look forward to working with the FDA on its review of our application, and to working with other regulatory agencies as we do everything we can to bring molnupiravir to patients around the world as quickly as possible.”

Merck and its partner Ridgeback Biotherapeutic said they specifically asked the agency to grant emergency use of the pill for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization.

“The value here is that it’s a pill so you don’t have to deal with the infusion centers and all the factors around that,” said Dr. Nicholas Kartsonis, a senior vice president with Merck’s infectious disease unit. “I think it’s a very powerful tool to add to the toolbox.”

An FDA decision on Merck’s COVID-19 pill could come down in a matter of weeks.