FDA

The FDA issued an Emergency Use Authorization (EUA) for the emergency use of molnupiravir for the treatment of mild-to-moderate COVID-19 in adults at high risk for progressing to severe COVID-19 disease, including hospitalization and death.

• Risk for progression includes age > 60, diabetes, obesity (BMI ≥ 30), chronic kidney disease, serious heart conditions, chronic obstructive pulmonary disease, or active cancer.
• Authorized for treatment within the first 5d of symptomatic COVID-19 illness.
• In February 2023, the FDA updated the EUA by removing the need for a positive COVID-19 viral test to prescribe the medication.

Molnupiravir is NOT authorized for:

• Patients < 18 years of age
• Patients requiring hospitalization for the management of COVID-19 disease (benefit has not been observed in patients beginning treatment after hospitalization)
• Use longer than 5 consecutive days
• Pre-exposure or post-exposure prophylaxis for the prevention of COVID-19 disease