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Lagevrio (molnupiravir)

Important Information About Lagevrio

Lagevrio (molnupiravir, MK-4482) is authorized for the treatment of mild to moderate COVID-19 in adults age 18 years and older, who are at high risk for progressing to severe COVID-19 and for whom alternative COVID-19 treatment options are not accessible or clinically appropriate. Lagevrio is an oral antiviral drug that is available by prescription only and should be initiated as soon as possible after diagnosis of COVID-19 and within five days of symptom onset.

Emergency Use Authorization of Lagevrio

The U.S. Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response (ASPR) will oversee the fair and equitable allocation of Lagevrio to state and territorial health departments and, select Health Resources and Services Administration (HRSA)-funded health centers.

HHS has purchased about 3 million courses of Lagevrio. An initial 300,000 courses of Lagevrio was shipped to states and territories arrived at dispensing sites by the end of December. Initial allocations of Lagevrio were determined on a pro rata basis and is provided to state and territorial health departments for free.

State and territorial health departments will allocate product to dispensing sites across their jurisdictions, and the distributor will ship product directly to sites, which include pharmacies, doctors’ offices, clinics, hospitals, urgent care centers, and local health departments.

Equity remains a top priority in the nation’s COVID-19 response. As part of our commitment to equitable access, HHS will identify a subset of 200 Health Resources and Services Administration (HRSA)-funded health centers across all 50 states to receive a direct allotment of Lagevrio each distribution cycle. This allotment will equal about 15% of the total product available to HHS in a given distribution period, and allocation of product to these centers will be separate from the pool of product allocated to states and territories. Health departments will have insight into selected HRSA-funded health centers and their product allocations and reporting. This effort will complement the focus health departments are already placing on equity by helping ensure Lagevrio is accessible to some of the most vulnerable communities and hard-hit populations around the country.

Lagevrio FDA EUA Resources