Merck asks FDA to clear promising anti-COVID pill

Drugmaker Merck on Monday asked U.S. regulators to clear its COVID-19 pill in what would add an entirely new and easy-to-use weapon to the global arsenal against the pandemic.

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

An antiviral pill that people could take at home to reduce symptoms and speed recovery could prove revolutionary, ease the overwhelming workload on U.S. hospitals, and help curb epidemics in poorer countries with health systems. weak health. It would also strengthen the two-pronged approach to the pandemic: treatment, through drugs, and prevention, mainly 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 have specifically asked the agency to grant emergency use to adults with mild to moderate COVID-19 who are at risk of serious illness or hospitalization. This is pretty much how COVID-19 infusion drugs are used.

“The value here is that it’s a pill, so you don’t have to worry about infusion centers and all the factors around them,” said Dr. Nicholas Kartsonis, senior vice president. from Merck’s Infectious Diseases Unit. “I think it’s a very powerful tool to add to the toolkit.”

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

Side effects were similar between patients who received the drug and those in a test group who received a dummy pill. But Merck has not publicly detailed the types of issues reported, which will be a key part of the FDA’s review.

US officials continue to promote vaccinations as the best way to protect against COVID-19. But with some 68 million eligible Americans still unwilling to be vaccinated, effective drugs will be essential to control future waves of infection.

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

Three antibody-based drugs cleared by the FDA have been shown to be very effective in reducing deaths from COVID-19, but they are expensive, difficult to produce, and require specialized equipment and medical professionals.

Assuming FDA clearance, the US government agreed to purchase enough pills to treat 1.7 million people, at a price of around $ 700 for each treatment. That’s less than half the price of antibody drugs bought by the US government – 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 does not represent the final price of the drug.

“We set this price before we had any data, so it’s just one contract,” Kartsonis said. “Obviously, we’re going to be responsible for this and making this drug as accessible as possible to as many people around the world as possible.”

Merck, based in Kenilworth, New Jersey, said it was in purchasing talks with governments around the world and would 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 studying similar drugs and are expected to release results in the coming weeks and months. AstraZeneca is also seeking FDA clearance for a long-acting antibody drug designed to provide months of protection for patients with immune system disorders and not responding adequately to vaccination.

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