Merck asks US Food and Drug Administration to approve a promising anti-COVID pill

Merck asked US regulators on Monday to approve its COVID-19 pill, which would add an entirely new and simple-to-use weapon to the world’s arsenal against the pandemic.

It would be the first pill shown to treat COVID-19 if approved by the Food and Drug Administration, which could happen in a matter of weeks. All other FDA-approved treatments for the disease necessitate an IV or injection.

An antiviral pill that people could take at home to reduce their symptoms and speed recovery could be game changer, relieving the strain on U.S. hospitals and aiding in the control of outbreaks in poorer countries with underdeveloped health-care systems. It would also strengthen the pandemic’s two-pronged approach of treatment and prevention, primarily through vaccinations.

Before making a decision, the FDA will review company data on the safety and effectiveness of the drug, molnupiravir.

Merck and its partner Ridgeback Biotherapeutic asked the FDA specifically for emergency use for adults with mild-to-moderate COVID-19 who are at risk of severe disease or hospitalization. That is roughly how COVID-19 infusion drugs are administered.

“The value here is that it’s a pill, so you don’t have to deal with infusion centers and all the other factors,” said Dr. Nicholas Kartsonis, senior vice president of Merck’s infectious disease unit. “I believe it is a very powerful tool to have in the toolbox.”

The company reported earlier this month that the pill reduced hospitalizations and deaths in patients with early COVID-19 symptoms by half. The findings were so compelling that independent medical experts overseeing the trial recommended that it be terminated early.

The side effects were comparable between patients who received the drug and those in a control group who received a dummy pill. However, Merck has not publicly disclosed the types of problems that have been reported, which will be an important part of the FDA’s investigation.

Vaccinations, according to US officials, are the best way to protect against COVID-19. However, with approximately 68 million eligible Americans still refusing to receive the vaccines, effective drugs will be critical to controlling future outbreaks of infection.

Since the start of the pandemic, health experts have emphasized the importance of a convenient pill. The goal is to create something similar to Tamiflu, a 20-year-old flu medication that shortens the illness by a day or two while also reducing the severity of symptoms such as fever, cough, and stuffy nose.

Three FDA-approved antibody drugs have proven to be highly effective in reducing COVID-19 deaths, but they are costly, difficult to produce, and require specialized equipment and health professionals to administer.

Assuming FDA approval, the US government has agreed to purchase enough pills to treat 1.7 million people at a cost of around $700 per course of treatment. That’s less than half the cost of the antibody drugs purchased by the US government — more than $2,000 per infusion — but still more than many antiviral pills for other conditions.

In an interview, Merck’s Kartsonis stated that the $700 figure does not represent the final price of the medication.

“We set that price before we had any data,” Kartsonis explained, “so that’s just one contract.” “Obviously, we’re going to be responsible about this and make this drug available to as many people as possible around the world.”

Merck, based in Kenilworth, New Jersey, has stated that it is in purchase talks with governments all over the world and will use a sliding price scale based on each country’s economic means. In addition, the company has signed licensing agreements with several Indian generic drug manufacturers to produce low-cost versions of the drug for low-income countries.

Several other companies, including Pfizer and Roche, are researching similar drugs and will report results in the coming weeks and months. AstraZeneca is also requesting FDA approval for a long-acting antibody drug designed to provide months of protection for patients with immune-system disorders who do not respond adequately to vaccination.

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