JACKSONVILLE, Fla. – Drugmaker Merck asked U.S. regulators Monday to authorize its pill for treating COVID-19 in what would add an entirely new and easy-to-use weapon to the world’s arsenal against the pandemic.
If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill shown to treat the illness. All other FDA-backed treatments against COVID-19 require an IV or injection.
The FDA will scrutinize company data on the safety and effectiveness of the drug, molnupiravir, before rendering a decision.
Merck and its partner Ridgeback Biotherapeutic said they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the way COVID-19 infusion drugs are used.
The company reported earlier this month that the antiviral pill cut hospitalizations and deaths by half among patients with early symptoms of COVID-19. The results were so strong that independent medical experts monitoring the trial recommended stopping it early.
Side effects were similar between patients who got the drug and those in a testing group who received a dummy pill. But Merck has not publicly detailed the types of problems reported, which will be a key part of the FDA’s review.
“So, basically, what it’s doing is it’s working on the virus’s RNA to prevent it from replicating. So, if a virus cannot replicate in your body, it cannot survive,” said Dr. Sunil Joshi, president of the Duval County Medical Society Foundation.
The treatment would be given as four pills taken twice a day for five days. The goal is for something similar to Tamiflu, the 20-year-old flu medication that shortens the illness by a day or two and blunts the severity of symptoms like fever, cough and stuffy nose.
“This is going to be much, much more convenient than the monoclonal and significantly less expensive — the kind of thing you can prescribe and, hopefully, have at a pharmacy to just pick up,” Joshi said.
Three FDA-authorized antibody drugs have proved highly effective at reducing COVID-19 deaths, but they are expensive, hard to produce and require specialty equipment and health professionals to deliver.
Assuming FDA authorization, the U.S. government has agreed to buy enough of the pills to treat 1.7 million people, at a price of roughly $700 for each course of treatment. That’s less than half the price of the antibody drugs purchased by the U.S. government — over $2,000 per infusion — but still more expensive than many antiviral pills for other conditions.
Top U.S. health officials continue to push vaccinations as the best way to protect against COVID-19. Joshi said he hopes people will continue to get vaccinated.
“Prevention is first and foremost for any disease process,” Joshi said. “But if you do get the virus, it’s good to have other treatment options that are more convenient and more readily available.”