Drugmakers Merck and Ridgeback Biotherapeutics announced Friday that they will seek authorization for an oral antiviral pill to fight COVID-19 after trial data shows it reduced risk of hospitalization and death by half.
The drug, known as molnupiravir, would be the first oral antiviral medicine for COVID-19 to receive Emergency Use Authorization from the U.S. Food and Drug Administration.
"More tools and treatments are urgently needed to fight the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families, and societies and strain health care systems all around the world," Robert Davis, Merck's president and CEO, said in a statement.
"At the interim analysis, molnupiravir reduced the risk of hospitalization or death by approximately 50%," the company said in a statement.
In a trial of 775 adults with mild-to-moderate COVID-19, who were considered higher risk for severe disease due to underlying health conditisions such as diabetes, obesity or heart disease, 7.3% of patients treated with the drug were hospitalized or died within 29 days, compared to 14.1% of those who received a placebo.
The drug also demonstrated "consistent efficacy" against the gamma, delta and mu variants of the coronavirus.
"With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic and will add to Merck’s unique legacy of bringing forward breakthroughs in infectious diseases when they are needed most," Davis added.
“With the virus continuing to circulate widely, and because therapeutic options currently available are infused and/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,” Wendy Holman, CEO of Ridgeback Biotherapeutics, added. “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."
Merck enterered into an agreement with the Biden Administration earlier this year to supply the U.S. government with 1.7 million doses of the drug, pending FDA authorization or approval.