Following disappointing clinical trial results with two COVID-19 vaccines of its own earlier in the year, drug manufacturer Merck is returning to the table with an oral treatment.
The company’s year-long clinical study involving the oral antiviral medicine molnupiravir -- a drug originally developed for the treatment of influenza -- found that the drug reduced the risk of hospitalization or death from the coronavirus by approximately 50%. With those results, Merck says it plans to seek Emergency Use Authorization (EUA) in the U.S.
One Merck spokesperson told ConsumerAffairs that molnupiravir’s potential could be game-changing. “Not only is it effective against COVID-19, but other coronavirus strains, as well,” they said.
Merck reported no deaths among those who received molnupiravir in its outpatient study. That compared to 8 deaths in patients who received a placebo.
“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,” said Robert M. Davis, chief executive officer and president, Merck. “With these compelling results, we are optimistic that molnupiravir can become an important medicine as part of the global effort to fight the pandemic.”
If granted approval, Merck says it’s prepared to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
Merck's plans for molnupiravir are global. In fact, the Phase 3 portion of the trial was conducted in more than 170 planned sites in countries including Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom, and the United States.
The company has already submitted marketing applications to other global drug regulators and stated that it plans to implement a tiered pricing approach if it is authorized or approved. It says the pricing system will reflect countries’ relative ability to finance their health response to the pandemic.