Merck (NYSE: MRK), known as MSD outside the United States and Canada, and Ridgeback Biotherapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for molnupiravir, an investigational oral antiviral (MK-4482, EIDD-2801). Molnupiravir has not been approved, but has been authorized for emergency use by the FDA under an EUA to treat mild to moderate coronavirus disease 2019 (COVID-19) in adults with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death, and for whom alternative COVID-19 treatment options authorized by the FDA are not accessible or clinically appropriate. Molnupiravir is not authorized for use in patients who are less than 18 years of age, for initiation of treatment in patients hospitalized due to COVID-19, for use for longer than five consecutive days, or for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
“The FDA Emergency Use Authorization of molnupiravir is an important milestone in the fight against COVID-19, and adds to Merck’s legacy of bringing forward innovative medicines that both address the world’s greatest health threats and help save lives. Because we recognized the promise of molnupiravir early, Merck invested at risk and we are executing an unprecedented global access strategy so that molnupiravir, now authorized, can be available to patients here in the U.S. and all around the world more quickly and more equitably than has ever been accomplished before,” said Robert M. Davis, chief executive officer and president, Merck.
Molnupiravir should be administered as soon as possible after a diagnosis of COVID-19 has been made, and within five days of symptom onset. The recommended dose for molnupiravir is 800 mg (four 200 mg capsules) taken orally every 12 hours for five days, with or without food. Completion of the full five-day treatment course is important to maximize viral clearance and minimize transmission of SARS-CoV-2.
Molnupiravir is not recommended for use in patients who are pregnant. Based on findings from animal reproduction studies, molnupiravir may cause fetal harm when administered to pregnant individuals. There are no available human data on the use of molnupiravir in pregnant individuals to evaluate the risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Before initiating treatment with molnupiravir, it should be assessed whether an individual of childbearing potential is pregnant or not, if clinically indicated. Females of childbearing potential should use a reliable method of contraception correctly and consistently, as applicable, for the duration of treatment and for four days after the last dose of molnupiravir. Males of reproductive potential who are sexually active with females of childbearing potential should use a reliable method of contraception correctly and consistently during treatment and for at least three months after the last dose. There is a pregnancy surveillance program that monitors pregnancy outcomes in individuals exposed to molnupiravir during pregnancy. Patients exposed to molnupiravir during pregnancy should report the exposure by contacting Merck by phone at 1-877-888-4231, or online at pregnancyreporting.msd.com. For more information, see “Selected Safety Information” below.
The authorization is based on the Phase 3 MOVe-OUT trial, which evaluated molnupiravir 800 mg twice-daily in non-hospitalized adult patients who were unvaccinated against SARS-CoV-2, had laboratory-confirmed SARS-CoV-2 infection, symptom onset within five days of study randomization, and at least one risk factor associated with poor disease outcomes (e.g., heart disease, diabetes).
In analyses from all randomized patients (n=1433), molnupiravir reduced the risk of hospitalization or death: 9.7% (68/699) of patients in the placebo group were hospitalized or died compared to 6.8% (48/709) of patients who received molnupiravir, for an absolute risk reduction of 3.0% (95% confidence interval [CI]: 0.1, 5.9). Nine deaths were reported in the placebo group, and one in the molnupiravir group.
The determination of primary efficacy was based on a planned interim analysis of 762 subjects. At the interim analysi...
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