Healthcare company Merck (NYSE:MRK) and Ridgeback Biotherapeutics on Thursday jointly announced the receipt of the U.S. Food and Drug Administration's (FDA) Emergency Use Authorization (EUA) for the investigational oral antiviral molnupiravir for COVID-19.
The partners added that Molnupiravir (MK-4482, EIDD-2801) is approved to treat mild to moderate coronavirus disease 2019 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.
According to the companies, molnupiravir should be administered within five days of symptom onset. The recommended dose for molnupiravir is 800mg (four 200mg capsules) taken orally every 12 hours for five days, with or without food.
Based on the Phase 3 MOVe-OUT trial, the partners evaluated molnupiravir 800mg twice-daily in non-hospitalized adult patients who were unvaccinated against SARS-CoV-2, 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, the companies' molnupiravir reduced the risk of hospitalization or death by 9.7% in patients. However, nine deaths were reported in the placebo group and one in the molnupiravir group.
Additionally, Merck plans to begin shipping molnupiravir to AmerisourceBergen, the sole distributor, within days.
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