Merck and Ridgeback Biotherapeutics are planning to seek emergency authorization for a new oral medication shown to reduce the risk of hospitalization or death by around 50% in mild to moderate COVID-19 cases.
The drug, molnupiravir, was tested in a clinical trial, which yielded “compelling” results. The drug inhibits the replication of the coronavirus within the body.
Seven percent of patients treated with molnupiravir in the trial were hospitalized within 29 days. No deaths were reported among patients who received molnupiravir in the 29-day period. Eight deaths were reported among placebo-treated patients.
Trial participants were unvaccinated and had at least one major risk factor for contracting severe COVID (obesity, age, diabetes or heart disease).
Molnupiravir was also shown to be effective at treating the highly transmissible delta strain. Only around 1.3% of participants who received the drug discontinued treatment due to an adverse side effect.
Dr. Anthony Fauci, White House chief medical advisor, commented on the development of the drug at a COVID briefing Friday. “The news of the efficacy of this particular antiviral is obviously very good news,” he said. “The company, when they briefed us last night, had mentioned that they will be submitting their data to the FDA imminently. The FDA will look at the data and in their usual, very efficient and effective way, will examine the data as quickly as they possibly can, and then it will be taken from there.”
Robert M. Davis, CEO and president of Merck, said the company is working as fast as possible to make the drug widely available to COVID patients. “With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global efforts to fight the pandemic.”
Ridgeback Biotherapeutics CEO Wendy Holman also commented: “With the virus continuing to circulate widely, and because therapeutic options currently available are infused or require access to a healthcare facility, antiviral treatments that can be taken at home to keep people with Covid-19 out of the hospital are critically needed. 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.”
