Former FDA head says Merck’s oral pill could become a powerful tool in combating COVID in high-risk patients who are already symptomatic. Merck cheered investors and healthcare experts alike on Friday with the news that its COVID-19 antiviral cut the risk of hospitalization or death by roughly half in a late-stage trial, and could become a powerful tool in reining in the pandemic.
The drug company MRK, 9.49% said molnupiravir, an oral antiviral developed with partner Ridgeback Biotherapeutics, reduced the risk of hospitalization or death in at-risk adult patients with mild to moderate COVID by about 50% in an interim analysis of data from a late-stage trial. The data came from 775 patients out of 1,550 that were enrolled in the trial. Merck shares soared 9% in early trades Friday as investors welcomed what would be a much-needed and long-awaited treatment for COVID. While several effective vaccines have been developed against the illness, far fewer treatments have emerged, and those that have require infusions and must be administered in a clinical setting.Molnupiravir is a pill administered orally in capsule form every 12 hours for five days, according to clinicaltrials.gov.Through Day 29 in the Phase 3 trial, no patients given molnupiravir died, compared with the eight patients who died on the placebo. The company is now planning to submit an application for emergency-use authorization for the treatment from the Food and Drug Administration and to seek authorizations from other regulatory bodies around the world.Merck plans to produce 10 million courses of treatment by year-end. The U.S. government has already committed to purchasing about 1.7 million courses of the drug, once it receives an EUA.
The company said it halted the study early at the recommendation of an independent data-monitoring committee and in consultation with the FDA, because the results were so positive.
Health experts applauded the news and said it would make a big difference in the fight against the coronavirus-borne illness, which has caused the deaths of almost 5 million people since the start of the outbreak.