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FDA Issues Emergency Authorization for Merck’s COVID-19 Treatment
In a Phase 3 trial, 6.8% of patients who received molnupiravir were hospitalized or died before the 29-day follow-up, compared to 9.7% of patients who received placebo.
FDA recently issued an emergency use authorization for Merck’s COVID-19 treatment, molnupiravir, for adults 18 years of age and older.
The agency authorized the treatment for adults with high risk of severe disease and for whom alternative treatment options are not accessible or clinically appropriate. Molnupiravir is available by prescription only and should be administered within five days of symptom onset.
Notably, molnupiravir is not authorized for the pre-exposure or post-exposure of COVID-19 or for treatment in hospitalized patients.
“Molnupiravir is limited to situations where other FDA-authorized treatments for COVID-19 are inaccessible or are not clinically appropriate and will be a useful treatment option for some patients with COVID-19 at high risk of hospitalization or death,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in the announcement.
“As new variants of the virus continue to emerge, it is crucial to expand the country’s arsenal of COVID-19 therapies using emergency use authorization, while continuing to generate additional data on their safety and effectiveness,” Cavazzoni continued.
Caregivers can administer molnupiravir as four 200 milligram capsules every 12 hours for five days. But the drug is not authorized for use longer than five consecutive days.
FDA based its decision on results from the MOVe-OUT trial, which studied molnupiravir in non-hospitalized patients with mild to moderate COVID-19 at high risk of severe disease and/ or hospitalization.
Patients in the trial had a prespecified chronic medical condition and had not received an FDA-approved COVID-19 vaccine.
In the trial, 6.8 percent of patients who received molnupiravir were hospitalized or died before the 29-day follow-up, compared to 9.7 percent of patients who received placebo.
In November, the UK Medicines and Healthcare products Regulatory Agency (MHRA) authorized molnupiravir for adults based on positive results from the Phase 3 MOVe-OUT trial.
In the trial, molnupiravir reduced the risk of hospitalization or death by nearly 50 percent. And 7.3 percent of patients who received the treatment were either hospitalized or died through Day 29, compared with 14.1 percent of placebo-treated patients.
Researchers reported no deaths in the molnupiravir group, while there were eight deaths in the placebo group.
