HEALTH

Merck asks US FDA to authorize promising anti-COVID pill

Oct 11, 2021, 6:21 AM | Updated: 6:55 am

covid pill...

This undated image provided by Merck & Co. shows their new antiviral medication. The drugmaker has said its experimental pill for people sick with COVID-19 reduced hospitalizations and deaths. (Merck & Co. via AP)

(Merck & Co. via AP)

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.

We want to hear from you.

Have a story idea or tip? Send it to the KSL NewsRadio team here.

Health

Mothers and mental health...

Mira Cheng, CNN

Maternal mental health conditions drive climbing death rate in US, research says

The maternal mortality rate in the US is two- to threefold greater than in other high-income countries and increasing.

13 minutes ago

A Gila monster is displayed at the Woodland Park Zoo in Seattle, Dec. 14, 2018....

MEAD GRUVER Associated Press

A Colorado man is dead after a pet Gila monster bite

A Colorado man has died after being bitten by his pet Gila monster in what would be a rare death if the creature's venom was the cause.

7 hours ago

students walk to a bus, kindness ewalls coming to utah's k-12 schools...

Britt Johnson

Schools in Utah to get Kindness eWalls

Kindness eWalls display positive messages submitted by a school's students, teachers and parents.

1 day ago

Exercise particularly reduced risk of death for women, according to the data....

Madeline Holcombe, CNN

Women might lower their risk for cardiovascular disease by twice the amount as men with exercise

The benefits of exercise are great for everyone – but may be even better for women, according to a new study.

1 day ago

FILE: Senate Minority Leader Luz Escamilla, D-Salt Lake City, speaks at a Senate Revenue and Taxati...

Eric Cabrera

Bill would authorize Medicaid to cover Indigenous healing services in Utah

A bill sponsored by the Senate minority leader authorizes the state to apply for a Medicaid waiver.

2 days ago

Sour gummy worms colored in red, green, yellow, and blue...

Mariah Maynes

Can sour candy ease anxiety and panic attacks?

Experts say a TikTok trend where people suck on sour candy to ease anxiety or panic attacks, can work.  

2 days ago

Sponsored Articles

Mother and cute toddler child in a little fancy wooden cottage, reading a book, drinking tea and en...

Visit Bear Lake

How to find the best winter lodging in Bear Lake, Utah

Winter lodging in Bear Lake can be more limited than in the summer, but with some careful planning you can easily book your next winter trip.

Happy family in winter clothing at the ski resort, winter time, watching at mountains in front of t...

Visit Bear Lake

Ski more for less: Affordable ski resorts near Bear Lake, Utah

Plan your perfect ski getaway in Bear Lake this winter, with pristine slopes, affordable tickets, and breathtaking scenery.

front of the Butch Cassidy museum with a man in a cowboy hat standing in the doorway...

Bear Lake Convention and Visitors Bureau

Looking Back: The History of Bear Lake

The history of Bear Lake is full of fascinating stories. At over 250,000 years old, the lake has seen generations of people visit its shores.

silhouette of a family looking over a lake with a bird in the top corner flying...

Bear Lake Convention and Visitors Bureau

8 Fun Activities To Do in Bear Lake Without Getting in the Water

Bear Lake offers plenty of activities for the whole family to enjoy without having to get in the water. Catch 8 of our favorite activities.

Wellsville Mountains in the spring with a pond in the foreground...

Wasatch Property Management

Advantages of Renting Over Owning a Home

Renting allows you to enjoy luxury amenities and low maintenance without the long-term commitment and responsibilities of owning a home.

Clouds over a red rock vista in Hurricane, Utah...

Wasatch Property Management

Why Southern Utah is a Retirement Paradise

Retirement in southern Utah offers plenty of cultural and recreational opportunities. Find out all that this region has to offer.

Merck asks US FDA to authorize promising anti-COVID pill