In a potential leap forward in the global fight against the pandemic, drugmaker Merck said Friday that its experimental pill for people sick with COVID-19 reduced hospitalizations and deaths by half.
If cleared by regulators, it would be the first pill shown to treat COVID-19, adding a whole new, easy-to-use weapon to an arsenal that already includes the vaccine.
The company said it will soon ask health officials in the U.S. and around the world to authorize the pill’s use. A decision from the U.S. Food and Drug Administration could come within weeks after that, and the drug, if it gets the OK, could be distributed quickly soon afterward.
All other COVID-19 treatments now authorized in the U.S. require an IV or injection. A pill taken at home, by contrast, would ease pressure on hospitals and could also help curb outbreaks in poorer and more remote corners of the world that don’t have access to the more expensive infusion therapies.
Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and death as those who received a dummy pill.
The study tracked 775 adults with mild-to-moderate COVID-19 who were considered high risk for severe disease because of health problems such as obesity, diabetes or heart disease. The results have not been reviewed by outside experts, the usual procedure for vetting new medical research.
Among patients taking molnupiravir, 7.3% were either hospitalized or died at the end of 30 days, compared with 14.1% of those getting the dummy pill. After that time period, there were no deaths among those who received the drug, compared with eight in the placebo group, according to Merck.
The results were so strong that an independent group of medical experts monitoring the trial recommended stopping it early.
Company executives said they plan to submit the data to the FDA in the coming days.