The US on Thursday authorised Merck & Co’s antiviral pill for COVID-19 for certain high-risk adult patients.
The US Food and Drug Administration (FDA) said Merck’s drug could be used when other authorised treatments are not accessible or clinically appropriate.
The drug, molnupiravir, was developed with Ridgeback Biotherapeutics and shown to reduce hospitalisation and deaths by around 30% in a clinical trial of high-risk individuals early in the course of the illness.
The authorisation allows the use of the drug for mild-to-moderate COVID-19 and along with the Pfizer pill, could be an important tool against the fast-spreading Omicron variant, which is now dominant in the United States.
Pfizer’s drug was authorised on Wednesday for people aged 12 and older and has shown to be nearly 90% effective in preventing hospitalisation and deaths in patients at high risk of severe illness, according to trial data.
The FDA says some patients should avoid Pfizer two-drug regimen because it includes an older antiviral called ritonavir that is known to have interactions with some other prescription medicines. It is also not recommended for people with severe kidney issues.
Merck plans to ship hundreds of thousands of treatment courses in the coming days and 1 million over the next few weeks. Pfizer plans to ship about 250,000 courses in the next month.
Availability of other treatments is the first consideration for doctors thinking of prescribing Merck’s treatment, according to Patrizia Cavazzoni, the director of FDA’s Center for Drug Evaluation and Research.
The drug is meant to be taken twice a day — four pills each time — for five days, making a full treatment course 40 pills. The treatment was priced at about $700 per course in a deal with the US government for up to 5 million courses.
The US government has ordered 10 million courses of the Pfizer drug at a price of $530 per course compares to the deal with Merck for as many as 5 million courses of molnupiravir at a price of $700 per course.
