Pharmaceutical Merck on Monday asked the US regulatory agency to authorize its COVID-19 drug, which would add a new, easy-to-use weapon to the world’s arsenal against the pandemic.
If approved by the U.S. Food and Drug Administration (FDA) – a decision that could be made in a matter of weeks – it would be the first pill proven to treat COVID-19. All other FDA-supported disease treatments require an injection or IV.
An antiviral pill that people could take at home to reduce their symptoms and speed their recovery would be a momentous advance that would reduce the burden on American hospitals and help fight outbreaks in poorer countries with vulnerable medical systems. It would also reinforce the strategy on two fronts of the pandemic: treatment with medication and prevention, especially through vaccines.
The FDA will study the company’s data on the safety and effectiveness of the drug, molnupiravir, before making a decision.
Merck and its partner Ridgeback Biotherapeutic said they specifically asked the FDA to authorize emergency use for adults with mild to moderate cases at risk of developing a severe condition or being hospitalized. These are roughly the cases in which medications are used intravenously.
“The value here is that it’s a pill, so infusion centers don’t have to deal with all the factors around that,” said Dr. Nicholas Kartsonis, vice president of Merck’s infectious diseases unit. “I think it is a very powerful tool to add to the repertoire.”
The company had reported this month that the pill roughly halved hospitalizations and deaths in patients with initial symptoms of COVID-19. The results were so clear that independent medical experts overseeing the trial recommended stopping it early.
Side effects were similar between patients who received the drug and those in the control group who received a placebo. However, Merck has not made public the reported problems, which could be decisive in the FDA’s decision.
The United States continues to view vaccinations as the best way to protect against COVID-19. But with 68 million Americans who could be immunized but still do not want to, effective drugs will be crucial in controlling new waves of infections.
Since the beginning of the pandemic, health experts have stressed the need for a convenient pill to use. The goal is to achieve something similar to Tamiflu, a medication introduced 20 years ago that reduces the duration of a flu by a day or two and reduces the severity of symptoms such as fever, cough and nasal congestion.
Three FDA-cleared antibody drugs have been shown to be highly effective in reducing deaths from COVID-19, but they are expensive, difficult to produce, and require specialized healthcare professionals and equipment to administer them.
If the FDA authorizes the drug, the US government has agreed to buy the pills to serve 1.7 million people at a cost of about $ 700 per treatment. It’s less than half the cost of US government-bought antibody drugs – about $ 2,000 per infusion – but it’s still more expensive than many antiviral pills for other diseases.
In an interview, Kartsonis said the $ 700 figure was not the final price of the medication.
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