CORONAVIRUS

Merck asks US FDA to authorize promising anti-COVID pill

Oct 11, 2021, 6:01 AM
(Merck via CNN)...
(Merck via CNN)
(Merck via CNN)

WASHINGTON (AP) — Drugmaker Merck asked U.S. regulators Monday to authorize its pill against COVID-19 in what would add an entirely new and easy-to-use weapon to the world’s arsenal against the pandemic.

If cleared by the Food and Drug Administration — a decision that could come in a matter of weeks — it would be the first pill 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 reduce their symptoms and speed recovery could prove groundbreaking, easing the crushing caseload on U.S. hospitals and helping to curb outbreaks in poorer countries with weak health care systems. It would also bolster the two-pronged approach to the pandemic: treatment, by way of medication, and prevention, primarily through vaccinations.

The FDA will scrutinize company data on the safety and effectiveness of the drug, molnupiravir, before rendering a decision.

Merck and its partner Ridgeback Biotherapeutic said they specifically asked the agency to grant emergency use for adults with mild-to-moderate COVID-19 who are at risk for severe disease or hospitalization. That is roughly the way COVID-19 infusion drugs are used.

“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,” said Dr. Nicholas Kartsonis, a senior vice president with Merck’s infectious disease 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 among patients with early symptoms of COVID-19. The results were so strong that independent medical experts monitoring the trial recommended stopping it early.

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

U.S. officials continue to push vaccinations as the best way to protect against COVID-19. But with some 68 million eligible Americans still unwilling to get the shots, effective drugs will be critical to controlling future waves of infection.

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

Three FDA-authorized antibody drugs have proved highly effective at reducing COVID-19 deaths, but they are expensive, hard to produce and require specialty equipment and health professionals to deliver.

Assuming FDA authorization, the U.S. government has agreed to buy enough of the pills to treat 1.7 million people, at a price of roughly $700 for each course of treatment. That’s less than half the price of the antibody drugs purchased by the U.S. 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 for the medication.

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

Kenilworth, New Jersey-based Merck has said it is in purchase talks with governments around the world and will use a sliding price scale based on each country’s economic means. Also, the company has signed licensing deals with several Indian generic drugmakers to produce low-cost versions of the drug for lower-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 also seeking FDA authorization for a long-acting antibody drug intended to provide months of protection for patients who have immune-system disorders and do not adequately respond to vaccination.

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

___

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content.

KSL 5 TV Live

Top Stories

Coronavirus

Police officers block Shanghai's Urumqi Road on Sunday. (Hector Retamal/AFP/Getty Images)...
CNN's Beijing bureau and Nectar Gan

Protests erupt across China in unprecedented challenge to Xi Jinping’s zero-Covid policy

Protests erupted across China throughout the weekend, including at universities and in Shanghai where hundreds chanted "Step down, Xi Jinping! Step down, Communist Party!"
1 day ago
Salt Lake City Police at the University of Utah Hospital due to a possible bomb threat. (Salt Lake ...
Michael Houck

Police: Unattended bag led to bomb squad response at U of U Hospital

Salt Lake City Police responded to a possible bomb threat at the University of Utah hospital Tuesday afternoon.
13 days ago
Evusheld...
Elizabeth Cohen and Naomi Thomas, CNN

COVID-19 medicine for immunocompromised patients is losing effectiveness

Judy Salins considers herself a smart, empowered patient, but until this week, she had no idea that the medicine she takes to defend herself against Covid-19 isn't protecting her as well as it used to.
17 days ago
Paxlovid, the antiviral pill that reduces the risk of hospitalization and death from Covid-19, also...
Jamie Gumbrecht, CNN

Paxlovid reduces risk of long Covid, Veterans Affairs study finds

Paxlovid, the antiviral pill that reduces the risk of hospitalization and death from Covid-19, also reduces the risk of long Covid, according to a new study by the US Department of Veterans Affairs.
22 days ago
President Joe Biden speaks at a Democratic National Committee event at the Howard Theatre on Octobe...
Darlene Superville, Associated Press

Biden to get updated COVID-19 booster shot, promote vaccine

President Joe Biden was scheduled to get his updated COVID-19 booster shot on Tuesday and urge the public to get theirs to ensure a healthy holiday season.
1 month ago
FILE: (L-R) Co-teachers at Yung Wing School P.S. 124 Marisa Wiezel (who is related to the photograp...
Collin Binkley, AP Education Writer

Test scores show historic COVID setbacks for kids across US

New national test results show that the pandemic spared no part of the country as it caused historic learning setbacks for America’s children.
1 month ago

Sponsored Articles

house with for rent sign posted...
Chase Harrington, president and COO of Entrata

Top 5 reasons you may want to consider apartment life over owning a home

There are many benefits of renting that can be overshadowed by the allure of buying a home. Here are five reasons why renting might be right for you.
Festive kitchen in Christmas decorations. Christmas dining room....
Lighting Design

6 Holiday Decor Trends to Try in 2022

We've rounded out the top 6 holiday decor trends for 2022 so you can be ahead of the game before you start shopping. 
Happy diverse college or university students are having fun on their graduation day...
BYU MBA at the Marriott School of Business

How to choose what MBA program is right for you: Take this quiz before you apply!

Wondering what MBA program is right for you? Take this quiz before you apply to see if it will help you meet your goals.
Diverse Group of Energetic Professionals Team Meeting in Modern Office: Brainstorming IT Programmer...
Les Olson

Don’t let a ransomware attack get you down | Protect your workplace today with cyber insurance

Business owners and operators should be on guard to protect their workplace. Cyber insurance can protect you from online attacks.
Hand turning a thermostat knob to increase savings by decreasing energy consumption. Composite imag...
Lighting Design

5 Lighting Tips to Save Energy and Money in Your Home

Advances in lighting technology make it easier to use smart features to cut costs. Read for tips to save energy by using different lighting strategies in your home.
Portrait of smiling practitioner with multi-ethnic senior people...
Summit Vista

How retirement communities help with healthy aging

There are many benefits that retirement communities contribute to healthy aging. Learn more about how it can enhance your life, or the life of your loved ones.
Merck asks US FDA to authorize promising anti-COVID pill