The company plans to apply for Emergency Use Authorization (EUA) with the US FDA based on the findings of the trial and there are also plans to submit marketing applications to other regulatory bodies worldwide.
The shares of American multinational pharmaceutical company Merck & Co., Inc (NYSE: MRK) is currently trading with good gains of 11% following the announcement from the company that the oral antiviral drug it developed as a treatment for COVID-19 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 Phase 3 trial. The company’s stock was changing hands at $83.66 at the time of writing.
The Merck trial featured 775 patients around the world, with the enrolled participants taking the COVID-19 medicine named molnupiravir, every 12 hours for five days. The company’s trial showed that 7.3% of those given molnupiravir were either hospitalized or had died by 29 days after treatment, compared with 14.1% of placebo patients. There were no deaths in the molnupiravir group, but there were eight deaths of placebo patients.
“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,” said Wendy Holman, chief executive officer of Ridgeback Biotherapeutics. “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. Our partnership with Merck is critical to ensuring rapid global access if this medicine is approved, and we appreciate the collaborative effort to reach this important stage of development.”
The duo of Merck and Ridgeback pointed out that the “incidence of any adverse event was comparable in the molnupiravir and placebo groups coming in at 35% and 40%, respectively.”
Merck COVID-19 Drug: Plans to Promote Accessibility
While millions of people around the world have either taken one or two shots of the COVID-19 vaccines produced by other competing pharmaceutical firms, Merck’s product is set to gain a competitive advantage with its oral administration style. As such, the company said it plans to promote accessibility to the medicine hinged on predefined partnerships with the US Government and other nations.
While the firm also confirmed it is pushing for new agreements with other countries, it said it will license their medicine to generic drug manufacturers that can help scale production and push the drugs to areas where they are most needed.
“As part of its commitment to widespread global access, Merck previously announced that the company has entered into non-exclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries (LMICs),” Merck said in a statement.
The company plans to apply for Emergency Use Authorization (EUA) with the US FDA based on the findings of the trial and there are also plans to submit marketing applications to other regulatory bodies worldwide.
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