Merck Asks FDA to Authorize Promising Covid-19 Pill – Smithsonian


Image of left hand holding four white capsules against a Merck-branded backdrop
The new antiviral pill could help unburden hospitals in states with low vaccination rates. NurPhoto via Getty Images

Earlier this week pharmaceutical company Merck announced it has submitted an application to the Food and Drug Administration (FDA) for emergency use of what could be the first-ever pill to treat Covid-19. Because the antiviral drug can be delivered in series of convenient and relatively inexpensive capsules, some experts say it could be a game-changer in the fight against the virus.

If the pill is approved by the FDA—which could happen in a matter of weeks—millions of Americans could be eligible to receive it. All other approved Covid-19 treatments must be delivered intravenously or injected by a medical professional, while the capsule could be taken at home as soon as symptoms appear. The pill, which contains the antiviral drug molnupiravir, won’t be a fix-all for the pandemic, but it will provide public health experts with another tool in their arsenal. Experts say vaccinations are the best way to protect oneself from infection, but the new antiviral medication provides a better shot for those that do fall ill. Around 68 million eligible Americans remain unvaccinated, underscoring the need for safe and effective treatments for Covid-19 infections.

“The value here is that it’s a pill so you don’t have to deal with the infusion centers and all the factors around that,” says Nicholas Kartsonis, a senior vice president with Merck’s infectious disease unit, to Matthew Perrone of the Associated Press. “It’s a very powerful tool to add to the toolbox.”

The drug molnupiravir, which was first tested for influenza, works by interfering with the way SARS-CoV-2 replicates inside our cells, causing mutations that kill the virus. In the company’s clinical trials, they reported that the pill halved hospitalizations and deaths in unvaccinated adults infected with Covid-19. The study group included adults who were already showing symptoms and were at a high risk of severe disease. The company says it’s seeking authorization for its pill to be given only to high-risk adults, like those over 60 or with other risk factors like obesity, diabetes, or heart disease. The results are not peer-reviewed, and the FDA will examine Merck’s studies on the drug before making a decision, reports Cassandra Willyard for Nature. Eventually, the FDA could approve the drug for lower-risk Americans, too. 

The medication isn’t a one-and-done pill: the company says people will have to take four pills twice a day for five days, for a total of 40 capsules. Merck, which is developing the pill with Ridgeback Biotherapeutics, anticipates producing enough pills for 10 million people by the end of this year. A similar antiviral pill being developed by Pfizer and Atea Pharmaceuticals-Roche, reports Rebecca Robbins for the New York Times. The new medication could also provide relief to over-burdened hospitals, especially in places where vaccination rates are still low. The pills cost about a third of the price of intravenous monoclonal antibody treatments with a price tag of around $700 USD per patient, but that may still be too costly for some nations.

“Are we going to be in a situation where the price is reasonable in low- and middle-income countries?” says Rachel Cohen, the North American executive director at the Drugs for Neglected Diseases initiative, to Nature. If those countries are able to get a supply of molnupiravir, they often lack the recourses needed to spot infections early. Because Merck’s pill must be taken within the first five days of showing symptoms, “that requires that we are able to actually rapidly diagnose people,” Cohen says, which “is actually a huge challenge.”

Because clinical trials included only high-risk, unvaccinated people, it’s not clear if the pill will be available to vaccinated people. A company spokeswoman said it would be up to the FDA to decide, according to the New York Times. Because of the way the drug works to kill the virus, people who are pregnant will not be eligible to receive the pills due to the risk of birth defects.

 

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