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Merck sought permission from the FDA.

WASHINGTON (AP) – Drug maker Merck on Monday called on U.S. regulators to allow its anti-Covid 19 pill to be added to the world’s arsenal against the epidemic as a completely new and easy-to-use weapon. ۔

If cleared by the Food and Drug Administration ایک a decision that could come in weeks-it would be the first pill to be shown to treat Covid 19. All other FDA-supported treatments against the disease require IV or injection.

An antiviral pill that people can take at home to reduce their symptoms and recover faster, reducing crushing cases on US hospitals and preventing outbreaks in poorer countries with weaker health care systems. Can be helpful It will also strengthen the two-pronged approach to the epidemic: treatment, medication, and prevention, primarily through vaccination.

The FDA will examine the company’s data before making a decision, regarding the safety and effectiveness of the drug, Molenpirver.

Merck and his partner, Raj Beck Biotherapeutic, said they specifically asked the agency to allow emergency use for mild to moderate COVID-19 adults who are at risk of serious illness or hospitalization. ۔ This is almost the same as the use of Covid 19 infusion drugs.

“The price here is that it’s a pill, so you don’t have to deal with the infusion centers and everything around it,” said Dr. Nicholas Cortinson, senior vice president of Merck’s Infectious Diseases Unit. “I think it’s a very powerful tool to add to the toolbox.”

The company reported earlier this month that the pill reduced hospital admissions and mortality in patients with early symptoms of COVID-19 by half. The results were so strong that independent medical experts overseeing the trial recommended that it be stopped immediately.

Side effects were similar between patients taking the drug and those in the testing group. But Merck did not elaborate on the types of issues reported publicly, which would be an important part of the FDA’s review.

U.S. officials continue to use vaccination as the best way to protect against code-19. But while some 68 million Americans are still unprepared to take shots, effective medication will be crucial to controlling future waves of infection.

Since the onset of the epidemic, health experts have stressed the need for a simple pill. The target is a 20-year-old flu medicine for something like Tamiflu, which reduces the illness for a day or two and reduces the severity of symptoms such as fever, cough and runny nose.

Three FDA-approved antibodies have been shown to be extremely effective in reducing deaths from Covid 19, but they are expensive, difficult to produce and require special equipment and health professionals to deliver. Is.

Accepting the FDA’s approval, the US government has agreed to purchase large quantities of pills to treat 1.7 million people, at a cost of about ڈالر 700 per course of treatment. This is less than half the cost of antibiotics purchased by the US government – more than $ 2,000 per infusion – but in other cases more expensive than many antiviral pills.

The figure of $ 700 does not represent the final price of the drug, Merck’s Courtins said in an interview.

“We set this price before we have any data, so it’s just a deal,” Cartesons said. “Obviously, we will be responsible for that and make this drug accessible to as many people as possible around the world.”

Merck, based in Kennel Worth, New Jersey, says it is negotiating purchases with governments around the world and will use price reductions based on each country’s economic resources. In addition, the company has signed licensing agreements with several Indian generic pharmaceutical companies to develop low-cost versions of the drug for low-income countries.

Several other companies, including Pfizer and Roche, are studying similar drugs and are expected to report results in the coming weeks and months. AstraZeneca is also seeking FDA approval for a long-acting antibody drug that aims to provide months of protection to patients with immune system disorders who do not respond properly to vaccinations. Are

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