The U.S. Food and Drug Administration authorized Merck & Co’s (MRK.N) antiviral pill as the second form of at-home treatment for the COVID-19 disease.
The regulatory agency said the pill is available for certain high-risk adult patients on Thursday. They announced the news a day after giving a general clearance to similar but more effective treatment from Pfizer Inc (PFE.N). According to Reuters, the drug will be used when other alternative treatments are not accessible or clinically appropriate.
Merck’s drug, molnupiravir, developed with Ridgeback Biotherapeutics, was shown to reduce hospitalizations and deaths by around 30% in a clinical trial of high-risk individuals early in the course of the illness. Therefore, the bureau approved the oral drug to treat mild-to-moderate COVID-19 in adults at risk for severe disease.
Both Merck and Pfizer pills could be promising tools against the fast-spreading Omicron variant, which is now dominant in the United States.
“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,” said Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research.
While molnupiravir is not permitted for patients under 18 due to bone and cartilage growth disorders, Pfizer’s drug, Paxlovid, became available on Wednesday for people aged 12 and older. According to trial data, the regimen has shown to be nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness.
The FDA stated that patients with severe kidney issues should avoid taking Pfizer’s two-drug treatment because it contains an older antiviral called ritonavir that is associated with some other prescription medicines.
“Merck plans to ship hundreds of thousands of treatment courses in coming days and 1 million over the next few weeks. Pfizer plans to ship about 250,000 courses in the next month,” Reuters reported.
The company said its treatment had advantages over the Pfizer pill. However, both antiviral regimens work by preventing the virus from replicating.
“It doesn’t require any second drug to boost its efficacy, and you can give it in a variety of special patient populations, including people who have significant issues with liver function or kidney function,” Nick Kartsonis, Merck’s senior vice president of clinical research for vaccines and infectious diseases, told Reuters.
“This approval comes at the right time since more COVID-19 treatments are needed to supplement the vaccination effort, especially in light of variants of concern,” said Cantor Fitzgerald analyst Louise Chen.
The U.S. government’s contract for 10 million courses of the Pfizer drug at $530 per course compares to the deal with Merck for as many as 5 million courses of molnupiravir for $700 per course.
Merck has said molnupiravir should be effective against any variant, including the new Omicron variant.