The Merck laboratory requests the FDA emergency authorization for its pill against COVID-19

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WASHINGTON - Drug maker Merck on Monday asked US regulators to authorize its pill against COVID-19, which reduces the risk of hospitalization or death in patients with this disease by about 50%, according to the company.

If authorized by the Food and Drug Administration (FDA) - a decision that could come in a matter of weeks - it would be the first pill that has been shown to treat the coronavirus.

All other FDA-backed treatments for the disease require an IV or injection.

An antiviral pill that people could take at home to reduce their symptoms and speed recovery would be the key to alleviating the crushing workload of American hospitals and help curb outbreaks in poorer countries with weak health systems.

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It would also reinforce the dual focus of the pandemic: treatment, through medication, and prevention, mainly through vaccination.

The FDA will review the company's data on the safety and efficacy of the drug, molnupiravir, before making a decision.

Merck and its partner Ridgeback Biotherapeutic specifically asked the agency to grant emergency use for adults with mild or moderate COVID-19 who are at risk of serious illness or hospitalization.

"The value here is that it's a pill, so you don't have to deal with vaccination centers and all the factors around that," said Dr. Nicholas Kartsonis, a senior vice president of Merck's infectious diseases unit.

"I think it is a very powerful tool to add to the toolbox."

The company reported earlier this month that the pill cut hospitalizations and deaths in half among patients with early symptoms of COVID-19.

The results were so compelling that the independent medical experts who supervised the trial recommended stopping it sooner.

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Side effects were similar between patients who received the drug and those in a test group who received a placebo pill.

But Merck has not publicly detailed the types of problems recorded, which will be a key part of the FDA's review.

US authorities continue to promote vaccination as the best way to protect against COVID-19.

However, since some 68 million Americans who are eligible to get vaccinated are still unwilling to do so, effective drugs will be critical to controlling future waves of infection.

Hispanics have one of the lowest rates of vaccination against COVID-19 in the United States.

Oct. 10, 202101: 44

Since the beginning of the pandemic, health experts have insisted on the need for a pill.

The goal is to achieve something similar to Tamiflu, the 20-year-old anti-flu medicine that shortens the illness by a day or two and lessens the severity of symptoms such as fever, cough, and nasal congestion.

Three FDA-cleared antibody drugs have been shown to be highly effective in reducing COVID-19 deaths, but they are expensive, difficult to produce, and require special equipment and healthcare professionals to administer.

Assuming the FDA authorizes them, the US government has agreed to buy enough pills to treat 1.7 million people, at an approximate price of $ 700 for each treatment.

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That's less than half the price of government-bought anti-antibody drugs - more than $ 2,000 per immunization - but it's still more expensive than many antiviral pills for other diseases.

The new antiviral pill from the pharmaceutical company Merck & Co. Merck & Co / AP

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 have data, so it's just a contract.

Obviously, we are going to be responsible in this regard and make this medicine accessible to as many people as possible around the world, ”said Kartsonis.

Merck, based in Kenilworth, NJ, has said it is in purchasing talks with governments around the world and will use a price scale based on the economic means of each country.

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In addition, the company has signed licensing agreements with several Indian generic drug manufacturers to produce low-cost versions of the drug for the most disadvantaged countries.

Other companies, such as Pfizer and Roche, are studying similar drugs and are expected to present results in the coming weeks and months.

AstraZeneca is also seeking FDA clearance for a long-acting antibody drug intended to provide months of protection to patients with immune system disorders who do not respond adequately to vaccination.

Over time, some experts foresee that several combination therapies will be prescribed against COVID-19 to improve protection against the worst symptoms of the virus.