Merck asks US FDA to authorize promising anti-COVID pill


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

If approved by the Food and Drug Administration – a decision that could come in just a few weeks – it would be the first pill to be shown to treat COVID-19. All other FDA-backed treatments against the disease require an IV or injection.

An antiviral pill that people could take at home to ease their symptoms and speed recovery could help ease the crushing caseload on US hospitals and contain outbreaks in poor countries with weak health care systems. It will also strengthen a two-pronged approach to the pandemic: treatment, through medicine, and prevention, primarily through vaccination.

The FDA will examine the company’s data on the safety and effectiveness of the drug, molnupiravir, before making a decision.

Merck and its partner Ridgeback Biotherapeutics said they specifically asked the agency to allow emergency use for adults with mild to moderate COVID-19 who are at risk of severe illness or hospitalization. Broadly speaking, this is how COVID-19 infusion drugs are used.

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

The company reported earlier this month that the pill cut hospitalizations and deaths by half in patients with early symptoms of COVID-19. The results were so strong that independent medical experts monitoring the trial recommended stopping it early.

Read also: Antibody injection reduces severe COVID-19 risk, AstraZeneca study concludes

Side effects were similar between patients taking the drug and those in a trial group that received the dummy pill. But Merck hasn’t publicly provided details of the types of reported problems, which will be a key part of the FDA’s review.

Top US health officials are pushing vaccination as the best way to protect against COVID-19.

Dr. Anthony Fauci, discussing Merck’s drug last week, said, “It’s much better to prevent yourself from getting infected than to treat the infection.”

Still, some 68 million eligible Americans have not been vaccinated, underscoring the need for effective drugs to control future waves of infection.

Since the start of the pandemic, health experts have stressed the need for a convenient pill. The goal is to do something similar to the 20-year-old flu drug Tamiflu to reduce illness by a day or two and blunt the severity of symptoms like fever, cough and stuffy nose.

Three FDA-authorized antibody drugs have proven highly effective in reducing COVID-19 deaths, but they are expensive, difficult to produce and require specialized equipment and healthcare professionals to distribute them.

Assuming FDA authorization, the US government has agreed to purchase enough pills to treat 1.7 million people, at a cost of about $700 for each course of treatment. That’s less than half the price of antibody drugs purchased by the U.S. government — more than $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 does not represent the final price of the drug.

“We set that price before we had any data, so it’s just a contract,” Kartsanis said. “Obviously we will be responsible about that and can get this drug to as many people around the world as possible.”

New Jersey-based Merck Kenilworth has said it is holding purchase talks with governments around the world and will use a sliding price scale based on each country’s economic means. In addition, the company has signed licensing deals 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 studying similar drugs and are expected to report results in the coming weeks and months. AstraZeneca is seeking FDA authorization for a long-acting antibody drug that aims to provide months of protection for patients who have immune-system disorders and do not respond adequately to vaccination. Huh.

Eventually some experts predict that different COVID-19 treatments will be prescribed in combination to better protect against the virus’s worst effects.

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