Merck Pharmaceuticals and Ridgeback Biotherapeutics announced Friday that their investigational oral drug, Molanupiravir, reduced the risk of hospitalization or death in at-risk adult patients with mild to moderate COVID-19 by 50 percent.
In response, Merck said it plans to apply to the Food and Drug Administration (FDA) for emergency use authorization "as soon as possible" to become the first oral antiviral for COVID-19.
In a comunicadoIn the interim analysis, only 7.3 percent of patients who received the antiviral were hospitalized or died, compared to 14.1 percent of those treated with placebo, the companies said.
They added that as of day 29, no deaths had been reported in patients receiving Molnupiravir, compared with 8 receiving placebo.
Thus, on the recommendation of an independent Data Monitoring Committee and in consultation with the FDA, recruitment for the study was stopped early due to these positive results. Merck plans to submit an Emergency Use Authorization (EUA) application to the U.S. FDA.
"More tools and treatments are urgently needed to combat the COVID-19 pandemic, which has become a leading cause of death and continues to profoundly affect patients, families and societies, and puts pressure on healthcare systems around the world" said Robert M. Davis, chief executive officer and president of Merck.
The businessman added that "with these compelling results, we are optimistic that Molnupiravir can become an important drug as part of the global effort to combat the pandemic."
For her part, Ridgeback Biotherapeutics CEO Wendy Holman noted that "because the virus continues to circulate widely and because currently available therapeutic options are injectable 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 sorely needed."
Results of the planned interim analysis of the drug for COVID-19
The planned interim analysis evaluated data from 775 patients who were initially enrolled in the phase trial on or before August 5, 2021. At the time of the decision to halt enrollment based on the compelling interim efficacy results, the trial was approaching full enrollment of the Phase 3 sample size of 1,550 patients, with more than 90 percent of the planned sample size already enrolled.
Eligibility criteria required all patients to have mild to moderate laboratory-confirmed COVID-19 with symptom onset within 5 days of study randomization.
In addition, Merck said, all patients were required to have at least one risk factor associated with a poor disease outcome at study entry.
Thus, Molnupiravir reduced the risk of hospitalization and/or death in all key subgroups; efficacy was not affected by timing of symptom onset or underlying risk factor.
In addition, according to participants with available viral sequencing data - approximately 40 percent of participants - Molnupiravir demonstrated consistent efficacy on Gamma, Delta and Mu viral variants.
In anticipation of possible FDA acceptance of emergency use, and in anticipation of the results, Merck is already producing Molnupiravir.
In that regard, Merck plans to produce 10 million treatments by the end of 2021, with more doses expected to be produced in 2022.
It has also committed to providing timely access to Molnupiravir globally, if licensed or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect the relative ability of countries to finance their health response to the pandemic.
In addition, the drugmaker announced that it has entered into non-exclusive voluntary licensing agreements for Molnupiravir with established generic manufacturers with the intention of accelerating the availability of the antiviral in more than 100 low- and middle-income countries.
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