The FDA Has Cleared the Second At-Home Covid Treatment
It was a good week for Merck as the Food and Drug Administration (FDA) has approved the company’s at-home Covid treatment.
The agency gave the green light to the company’s antiviral pill to treat Covid-19 for emergency use on Thursday.
Merck’s treatment, known as molnupiravir, was developed in partnership with Ridgeback Biotherapeutics. It is now cleared for use in adults with mild to moderate Covid who are at risk for severe disease, the agency said in a statement.
It was also this week that the FDA authorized another antiviral drug, from Pfizer. Pfizer’s pill was authorized for people as young as 12. The agency said molnupiravir is not authorized for use in patients under age 18 because the medication may affect bone and cartilage growth.
The use of Merck’s molnupiravir will be limited to situations where other authorized treatments are inaccessible or not “clinically appropriate,” said Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
“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,” she added.
Compared to Pfizer’s pill, Merck’s pill can be taken at home, and does not require an IV or injection.
Clinical trials found that the treatment reduced the risk of hospitalization and death among high-risk Covid patients by 30 percent. Pfizer’s drug has been shown to be 89 percent effective at preventing high-risk people from being hospitalized or dying from Covid.
The U.S. has already agreed to purchase about 3.1 million courses of Merck’s drug for $2.2 billion.
According to the company, it is ready to ship “hundreds of thousands” of courses within days and 1 million courses over the next few weeks in the U.S.
Disclaimer: We have no position in any of the companies mentioned and have not been compensated for this article.