Merck asks FDA to authorize promising anti-Covid-19 pill
WASHINGTON (AP) — 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.
An antiviral pill that people could take at home to reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload on U.S. hospitals and helping to curb outbreaks in poorer countries with weak health care systems. It would also bolster the twopronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.
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 value here is that it's a pill so you don't have to deal with the infusion centers and all the factors around that," said Dr. Nicholas Kartsonis, a senior vice president with Merck's infectious disease unit. "I think it's a very powerful tool to add to the toolbox."
The company reported earlier this month that the 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.
Top U.S. health officials continue to push vaccinations as the best way to protect against Covid-19.
"It's much, much better to prevent yourself from getting infected than to have to treat an infection," Dr. Anthony Fauci said while discussing Merck's drug last week.
Still, some 68 million eligible Americans remain unvaccinated, underscoring the need for effective drugs to control future waves of infection.
The prospect of a Covid-19 pill comes amid other encouraging signs: New cases per day in the U.S. have dropped below 100,000 on average for the first time in over two months, and deaths are running at about 1,700 a day, down from more than 2,000 three weeks ago.
Also, the average number of vaccinations dispensed per day has climbed past 1 million, an increase of more than 50% over the past two weeks, driven by the introduction of booster shots and workplace vaccine requirements.