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Merck asks US FDA to authorize promising anti-COVID pill | St. Louis News Headlines – St. Louis, Missouri

St. Louis, Missouri 2021-10-11 06:02:00 –

Washington (AP) — Pharmaceutical company Merck requested US regulators on Monday to approve tablets for COVID-19, adding a whole new and easy-to-use weapon to the global arsenal against pandemics.

If approved by the Food and Drug Administration (which may be decided within a few weeks), it will be the first tablet to be shown to treat COVID-19. All other FDA-assisted treatments for this disease require IV or injections.

Antiviral drugs that people can take at home to relieve symptoms and speed recovery prove to be groundbreaking, reduce the overwhelming number of cases in US hospitals, and have a weak healthcare system. Helps control outbreaks in poor countries. It will also reinforce a two-sided approach to pandemics: dosing treatment and predominantly vaccination prophylaxis.

Before making a decision, the FDA will scrutinize corporate data on the safety and efficacy of the drug molnupiravir.

Merck and its partner Ridgeback Biotherapeutic said they specifically requested authorities to permit emergency use of adults with mild to moderate COVID-19 at risk of severe illness or hospitalization. It is roughly the method in which COVID-19 infusions are used.

Dr. Nikola Skirt Sonnis, Senior Vice President of Merck’s Infectious Diseases Unit, said: “I think adding to the toolbox is a very powerful tool.”

Earlier this month, the company reported halving hospitalizations and deaths for patients with early symptoms of COVID-19. The results were so strong that an independent medical professional monitoring the trial recommended that the trial be stopped early.

Side effects were similar between patients taking the drug and patients in the test group who took the dummy pill. However, Merck does not publicly detail the types of problems reported. This will be an important part of the FDA’s review.

US authorities continue to promote vaccination as the best way to protect against COVID-19. However, about 68 million eligible Americans have not yet wanted to fire, so effective drugs will be important in controlling the wave of future infections.

Since the beginning of the pandemic, health professionals have emphasized the need for convenient tablets. The goal is to resemble Tamiflu, a 20-year-old flu drug that reduces illness by a day or two and reduces the severity of symptoms such as fever, cough, and stuffy nose.

The three FDA-approved antibody drugs have proven to be very effective in reducing COVID-19 mortality, but are expensive, difficult to manufacture, and need to be provided by specialized equipment and medical professionals. there is.

Given FDA approval, the US government has agreed to buy enough tablets to treat 1.7 million people at a price of about $ 700 per course of treatment. It’s less than half the price of antibody drugs purchased by the US government (more than $ 2,000 per infusion), but even more expensive than many antiviral drugs in other conditions.

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

“It’s just one contract because we set the price before we got the data,” says Kartsonis. “Obviously, we are responsible for this and will make this drug available to as many people as possible around the world.”

Based in Kenilworth, NJ, Merck is in talks with governments around the world to use the sliding price scale based on national economic instruments. The company also has license agreements with several Indian generic drug manufacturers to produce low-cost, low-cost medicines for low-income countries.

Several other companies, including Pfizer and Roche, are researching similar drugs and will report results within the next few weeks to months. AstraZeneca is also seeking FDA approval for long-acting antibody drugs aimed at providing months of protection to patients with immune system disorders who do not respond appropriately to vaccination.

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


The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.

Copyright 2021 AP communication. all rights reserved. This material may not be published, broadcast, rewritten, or redistributed without permission.

Merck asks US FDA to authorize promising anti-COVID pill | St. Louis News Headlines Source link Merck asks US FDA to authorize promising anti-COVID pill | St. Louis News Headlines

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