Pharmaceutical Merck asks FDA to clear its coronavirus pill

Pharmaceutical company Merck on Monday asked US regulators to authorize its COVID-19 pill in what it would add a brand new easy gun to use the global arsenal against the pandemic.

If approved by the Food and Drug Administration (FDA), a decision that could be made in a few weeks, it would be the first pill proven to treat COVID-19. All other FDA supported disease treatments require an IV or an injection.

Nail antiviral pastilla that people could take at home to reduce symptoms and speed recovery it could be revolutionary alleviate the overwhelming workload in hospitals.

AND help stop flare-ups in the poorest countries with weak health care systems. It would also strengthen the dual approach to the pandemic: treatment, by medication, and prevention, mainly through vaccines.

Molnupiravir: who can take it

The FDA will review 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 agency to grant the adult emergency use with COVID-19 mild to moderate who are at risk of serious illness or hospitalization. This is pretty much how COVID-19 infusion drugs are used.

“The value here is that it’s a pill, so you don’t have to worry about infusion centers and all the factors around it,” said Dr. Nicholas Kartsonis, vice president. senior in the infectious diseases unit at Merck. “I believe it is a very powerful tool to add to the toolbox “.

The company reported earlier this month that the pill halved hospitalizations and deaths among patients with first symptoms of COVID-19. The results were so strong that independent medical experts who oversaw the trial recommended stopping it early.

Side effects were similar between the patients who received the drug and those in the test group who received a dummy pill. But Merck has not publicly detailed the types of problems reported, what will be a key element of FDA review.

U.S. officials continue to promote vaccines as the best way to protect against COVID-19. But with about 68 million Americans who are not yet ready to be vaccinated, effective drugs will be essential to control future waves of infection.

Since the start of the pandemic, health experts have emphasized the need for a pill practice. The goal is something similar to Tamiflu, the flu medicine that shortens the illness by a day or two and eases the severity of symptoms such as fever, cough, and nasal congestion.

Remedies already approved

Three FDA-approved antibody drugs have been shown to be very effective to reduce deaths from COVID-19, but they are expensive, difficult to produce and require specialized equipment and health professionals for distribution.

Assuming FDA clearance, the US government agreed to buy enough pills to treat 1.7 million people, priced at around $ 700 for each treatment.

That’s less than half the price of antibody drugs bought by the US government, over $ 2,000 per injection, but still more expensive than many antiviral pills for other conditions.

Merck’s Kartsonis said in an interview that the $ 700 figure does not represent the final price of the drug.

“We set that price before we got any data, so it’s just a contract,” Kartsonis said. “Obviously, we will be responsible for it and we will make this drug be the most accessible for as many people in the world as we can. “

Merck, based in Kenilworth, New Jersey, said it was in purchase negotiations with governments around the world and would use a sliding price scale based on each country’s economic means.

In addition, the company signed license agreements with several Indian generic drug manufacturers to produce low cost versions of the drug for low income countries.

Other projects

Several other companies, including Pfizer and rock, are studying similar drugs and are expected to release the results in the coming weeks and months.

AstraZeneca too looking for FDA clearance for drug antibody Long-acting intended to provide months of protection for patients with impaired immune system and not responding adequately to vaccination.

Over time, some experts predict that various therapies will be prescribed COVID-19 in combination to better protect against the worst effects of the virus.

Associated press

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