Merck asks FDA to authorize first pill to treat COVID-19

Merck requested US authorities on Monday to approve its COVID-19 tablet, which would provide an entirely new and simple weapon to the global armory against the epidemic.

Information About First Pill For Treatment for Covid-19 made by Merck

It would be the first medication demonstrated to treat COVID-19 if approved by the Food and Drug Administration, which may happen in a matter of weeks. All other FDA-approved therapies for the illness necessitate the use of an IV or injection.

An antiviral tablet that individuals might take at home to relieve symptoms and hasten recovery could be revolutionary, reducing the burden on U.S. hospitals and assisting in the containment of epidemics in poorer nations with inadequate health care systems. It would also support the pandemic’s two-pronged strategy, which includes both treatment and prevention, largely through vaccines.

Before making a judgment, the FDA will examine corporate data on the medication molnupiravir’s safety and efficacy.

Merck and its partner Ridgeback Biotherapeutic stated they requested emergency approval for people with mild-to-moderate COVID-19 who are at risk of severe illness or hospitalization. COVID-19 infusion medicines are used in a similar manner.

“The value here is that it’s a tablet,” said Dr. Nicholas Kartsonis, a senior vice president with Merck’s infectious disease unit. “You don’t have to deal with infusion facilities and all the issues around that.” “It’s a really strong tool to have in your toolbox,” says the author.

The firm said earlier this month that the tablet reduced hospitalizations and fatalities in individuals with early COVID-19 symptoms by half. The findings were so compelling that independent medical professionals overseeing the experiment advised that it be terminated early.

Patients who took the medication and those in a testing group who received a fake tablet experienced comparable side effects. Merck, on the other hand, has not made public the sorts of issues that have been documented, which will be a significant element of the FDA’s investigation.

Vaccination remains the best approach to defend against COVID-19, according to US authorities. However, with 68 million eligible Americans still refusing to receive the injections, effective medicines will be crucial in preventing future outbreaks.

Health experts have emphasized the need for a handy pill since the outbreak began. The objective is to create something comparable to Tamiflu, a 20-year-old flu drug that reduces the severity of symptoms including fever, cough, and stuffy nose by a day or two.

Three FDA-approved antibody medicines have shown to be extremely successful in decreasing COVID-19 fatalities, but they are costly, difficult to manufacture, and need specialized equipment and health experts to administer.

The US government has committed to buy enough tablets to treat 1.7 million patients, assuming FDA approval, at a cost of around $700 per course of therapy. That’s less than half the cost of antibody medicines acquired by the US government, which cost more than $2,000 each infusion, but it’s still more than many antiviral tablets for other diseases.

In an interview, Merck’s Kartsonis stated that the $700 number does not represent the medication’s ultimate pricing.

“We established that pricing before we got any data,” Kartsonis explained, “so that’s just one contract.” “Obviously, we’re going to be responsible and make this medicine available to as many people as possible all around the world.”

Merck, located in Kenilworth, New Jersey, has said that it is in negotiations with governments across the world about purchasing its products, and that it will employ a sliding price scale based on each country’s economic resources. In addition, the business has secured licensing agreements with a number of Indian generic pharma companies to develop low-cost copies of the medication for low-income nations.

Pfizer and Roche, among others, are testing comparable medicines and are likely to release results in the next weeks and months. AstraZeneca is also requesting FDA approval for a long-acting antibody medication that would give months of protection for individuals with immune-system abnormalities who do not react well to vaccination.

Some scientists believe that in the future, different COVID-19 treatments will be administered in conjunction to better guard against the virus’s worst consequences.

Credit and source of news CBSNews 


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