Merck plans to seek emergency use authorization for molnupiravir as the first oral treatment for COVID-19.
Molnupiravir (MK-4482, EIDD-2801), an investigational oral antiviral medicine to treat COVID-19, significantly reduced the risk of hospitalization or death, according to Merck and Ridgeback Biotherapeutics.
At a planned interim analysis of molnupiravir’s phase 3 trial in at-risk, non-hospitalized adult patients with mild-to-moderate COVID-19, the oral antiviral reduced the risk of hospitalization or death by about 50%, the pharma makers said in a press release.
Notably, based on the participants with available viral sequencing data (around 40%), molnupiravir demonstrated consistent efficacy across viral variants Gamma, Delta, and Mu.
At the recommendation of an independent data monitoring committee and in consultation with the FDA, recruitment into the study is being stopped early due to the positive results, Merck and Ridgeback said. In addition, Merck plans to submit an application for emergency use authorization (EUA) to the FDA as soon as possible and plans to submit marketing applications to other regulatory bodies worldwide.
In anticipation of the results from the MOVe-OUT trial, Merck has been producing molnupiravir at risk, and expects to produce 10 million courses of treatment by the end of 2021, with more doses expected to be produced in 2022.
Earlier this year, Merck entered into a procurement agreement with the U.S. government under which Merck will supply about 1.7 million courses of molnupiravir, upon EUA or approval from the FDA.
Additionally, Merck has entered into supply and purchase agreements for molnupiravir with other governments worldwide, pending regulatory authorization, and is currently in discussions with other governments.
“Merck is committed to providing timely access to molnupiravir globally, if it is authorized or approved, and plans to implement a tiered pricing approach based on World Bank country income criteria to reflect countries’ relative ability to finance their health response to the pandemic,” the two companies said.
In addition, Merck previously announced that the company has entered into nonexclusive voluntary licensing agreements for molnupiravir with established generic manufacturers to accelerate availability of molnupiravir in more than 100 low- and middle-income countries following approvals or emergency authorization by local regulatory agencies.
“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 M. Davis, CEO and president of Merck, said in a statement. “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.”
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, CEO 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.”
The planned interim analysis evaluated data from 775 patients who were initially enrolled in the phase 3 trial on or prior to Aug. 5, 2021.
Researchers found that 7.3% of patients who received molnupiravir were either hospitalized or died through day 29 following randomization, compared with 14.1% of placebo-treated patients. Through day 29, no deaths were reported in patients who received molnupiravir, compared with eight deaths in patients who received the placebo.