As long expected, the U.S. government is winding down its distribution of COVID-19 countermeasures.
Merck & Co.’s antiviral Lagevrio is expected to transition from government-managed distribution to a commercial market next month, according to a statement from the U.S. Department of Health and Human Services' Administration for Strategic Preparedness and Response.
Before November, the government will gradually “wind down” its Lagevrio distribution to make the most use of its current supply. This past Monday, officials moved to a request-based approach.
It’s been somewhat of a bumpy ride for Lagevrio since the drug scored FDA authorization in 2021 as a treatment for recently infected patients who are at risk of progressing to a more severe form of the virus.
Pfizer’s Paxlovid nod came just before Merck’s authorization, and the Pfizer drug garnered significantly more uptake, partly due to Paxlovid’s superior efficacy in clinical trials.
Still, Merck’s treatment picked up $5.7 billion in 2022 sales.
Back in February, Lagevrio flopped in a phase 3 trial evaluating its ability to protect uninfected participants living with a recently diagnosed COVID-19 patient.
Days later, Europe’s Committee for Medicinal Products for Human Use dealt the drug another hit when it recommended against authorization, citing a lack of proven clinical benefit.
More recently, Lagevrio was linked to a potential increase in virus mutations. Merck disputed the report, pointing to data that show its med “impairs viral replication and reduces viral shedding which would reduce the risk of transmission.”
The company currently expects its Lagevrio revenue to come in around $1 billion for this year.