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Merck asks US FDA to approve promising anti-COVID pill

Drug maker Merck on Monday called on U.S. regulators to approve its pill against COVID-19, which would add an entirely new and easy-to-use weapon to the global arsenal against the pandemic.

If it were approved by the Food and Drug Administration – a decision that could be made in a matter of weeks – it would be the first pill that has been shown to be treated COVID-19. All other FDA-sponsored treatments for the disease require an IV or injection.

An antiviral pill that people could take at home to relieve their symptoms and speed recovery could prove groundbreaking in reducing the crushing case numbers in US hospitals and helping prevent outbreaks in poorer countries with weakness Health systems. It would also strengthen the two-pronged approach to the pandemic: treatment through medication and prevention, mostly through vaccination.

The FDA will review the company’s data on the safety and effectiveness of the drug molnupiravir before making a decision.

Merck and his Ridgeback biotherapeutic partner said they had specifically asked the agency to provide emergency treatment to adults with mild to moderate COVID-19 who are exposed to severe illness or hospitalization. That’s roughly the way COVID-19 medication for infusion is 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 them,” said Dr. Nicholas Kartsonis, Senior Vice President of the Infectious Diseases Division of Merck. “I think it’s a very powerful tool to add to the toolbox.”

The company reported earlier this month that the pill reduced hospital stays and deaths in patients by half with early symptoms of COVID-19. So convincing were the results that independent medical experts who monitored the study recommended that it end early.

The side effects were similar in patients who received the drug and those in a test group who received a dummy pill. However, Merck has not publicly detailed the nature of the reported issues the FDA review.

Senior U.S. health officials continue to urge vaccinations as the best protection against COVID-19.

“It is much, much better to protect yourself from infection than to have to treat an infection,” said Dr. Anthony Fauci when talking about Merck’s drug last week.

Still, approximately 68 million eligible Americans remain unvaccinatedwhich underscores the need for effective drugs to control future waves of infection.

Since the pandemic began, health experts have emphasized the need for a convenient pill. The goal is something similar to Tamiflu, the 20-year-old flu drug that cuts illness by a day or two and relieves the severity of symptoms such as fever, cough, and nasal congestion.

Three FDA-approved antibody drugs have been shown to be highly effective Reduce COVID-19 deaths, but they are expensive, difficult to manufacture, and require specialized equipment and healthcare professionals.

Assuming FDA approval, the US government has agreed to buy enough of it the pills used to treat 1.7 million people, at a price of about $ 700 for each treatment. That’s less than half the price of antibody drugs the US government bought – over $ 2,000 per infusion – but still more expensive than many antiviral pills for other conditions.

Kartsonis from Merck said in an interview that the The $ 700 number does not represent the final price of the drug.

“We set that price before we had dates, so it’s just a contract.” Kartsonis called. “Of course we will be responsible for making this drug available to as many people around the world as possible.”

Kenilworth, New Jersey, resident Merck has said it is in buying talks with governments around the world and will use a sliding price scale based on each country’s economic opportunities. The company has also signed licensing agreements with several Indian generic drug companies to produce low-cost versions of the drug for lower-income countries.

Several other companies including Pfizer and rock, are studying similar drugs and are expected to provide results in the coming weeks and months. AstraZeneca is also filing for FDA approval for a long-acting antibody drug that is said to protect patients with immune system disorders for months and does not respond adequately to vaccination.

After all, some experts predict different ones COVID-19 therapiesis prescribed in combination to better protect yourself from the worst effects of the virus.

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