Merck asks US FDA to approve promising anti-COVID pill


Drug maker Merck on Monday asked U.S. regulators to approve its pill to treat 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 few weeks – it would be the first pill proven to treat the disease. All other FDA-sponsored treatments for COVID-19 require an IV or injection.

An antiviral pill people could take at home to relieve their symptoms and speed recovery could prove groundbreaking, reducing the crushing case burden of U.S. hospitals, and helping contain outbreaks in poorer countries with weak 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 its partner Ridgeback Biotherapeutic 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 infusion drugs are 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 that go with them,” said Dr. Nicholas Kartsonis, Senior Vice President of Infectious Diseases at Merck. “I think it’s a very powerful tool to add to the toolbox.”

The company reported earlier this month that the pill cut hospital stays and deaths by half in those with early symptoms of COVID-19. The results were so convincing 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, which will be an important part of 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 unvaccinated, underscoring the need for effective drugs to control future waves of infection.

The prospect of a COVID-19 pill comes amid other encouraging signs: New cases per day in the US have averaged below 100,000 for the first time in over two months, and the death toll is around 1,700 per day, down from more than 2,000 three weeks ago.

The average number of vaccinations given per day has also risen to over 1 million, an increase of more than 50% in the past two weeks, driven by the introduction of booster vaccinations and vaccine needs in the workplace.

Still, health officials are preparing for another possible spike as the cold weather pushes more people into the home.

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 very effective in reducing COVID-19 deaths, but they are expensive, difficult to make, and require specialized equipment and healthcare professionals.

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

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

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

Kenilworth, New Jersey-based Merck has announced that it is in sales 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 Roche, 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.

Some experts predict that various COVID-19 therapies will eventually be prescribed in combination to better protect against the virus’ worst effects.

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