Medical experts monitoring the trial recommended stopping it early because interim results were so strong
Drugmaker Merck said Friday that its experimental COVID-19 pill reduced hospitalizations and deaths by half in people recently infected with the coronavirus and that it would soon ask health officials in the U.S. and around the world to authorize its use, the Associated Press reports.
If cleared, the drug would be the first pill shown to treat COVID-19, a potentially major advance in efforts to fight the pandemic. All COVID-19 therapies now authorized in the U.S. require an IV or injection.
Merck and its partner Ridgeback Biotherapeutics said early results showed patients who received the drug, called molnupiravir, within five days of COVID-19 symptoms had about half the rate of hospitalization and death as patients who received a dummy pill. The study tracked 775 adults with mild-to-moderate COVID-19 who were considered higher risk for severe disease due to health problems such as obesity, diabetes or heart disease.
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. There were no deaths in the drug group after that time period compared with eight deaths in the placebo group, according to Merck. The results were released by the company and have not been peer reviewed by outside experts, the usual procedure for vetting new medical research. Merck said it plans to present them at a future medical meeting.
An independent group of medical experts monitoring the trial recommended stopping it early because the interim results were so strong. That is typical when early results so clearly show a treatment works that there is no need for further testing before applying for authorization. Company executives said they plan submit the data for review by the Food and Drug Administration in coming days. Once the submission is complete, the FDA could make a decision within weeks — and, if approved, the drug could be on the market soon after.
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