Merck asks US FDA to authorize promising anti-COVID pill

If cleared by the Food and Drug Administration, it would be the first pill shown to treat COVID-19, adding a new, easy-to-use weapon to the world's arsenal against the pandemic.

Posted: Oct 11, 2021 5:51 AM
Updated: Oct 11, 2021 9:49 AM

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.

Top U.S. health officials continue to push vaccinations as the best way to protect against COVID-19.

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

Still, some 68 million eligible Americans remain unvaccinated, underscoring the need for effective drugs to control 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.

___

Minnesota Coronavirus Cases

Data is updated nightly.

Cases: 770246

Reported Deaths: 8661
CountyCasesDeaths
Hennepin1537491923
Ramsey63444980
Dakota57071526
Anoka54052520
Washington33690331
Stearns28419253
St. Louis23735361
Scott21652160
Wright21388171
Olmsted18144120
Sherburne15515115
Carver1366556
Clay1025399
Rice9985131
Blue Earth966659
Crow Wing9518109
Chisago837263
Kandiyohi835197
Otter Tail8061105
Benton7477111
Beltrami658079
Mower645541
Douglas629190
Goodhue619985
Itasca618885
Winona611854
McLeod595770
Steele585825
Isanti573074
Morrison557767
Becker534862
Polk512879
Freeborn487642
Nobles481652
Lyon456356
Carlton446866
Nicollet434454
Pine428532
Cass425745
Mille Lacs416967
Brown411547
Todd400036
Le Sueur386332
Meeker356854
Waseca327331
Martin326336
Wabasha29538
Hubbard292744
Dodge273510
Roseau265227
Fillmore243812
Redwood240443
Wadena238429
Houston231117
Renville228549
Faribault220630
Pennington217227
Sibley211612
Cottonwood197128
Kanabec192230
Chippewa190340
Aitkin184043
Watonwan171112
Pope16148
Yellow Medicine157220
Rock155319
Jackson147315
Koochiching138619
Clearwater136618
Murray135011
Swift134619
Marshall134520
Pipestone133427
Stevens124911
Lake109521
Wilkin102814
Lac qui Parle98524
Mahnomen90312
Norman8789
Big Stone7974
Grant7869
Lincoln7845
Kittson61122
Red Lake5899
Unassigned538124
Traverse5165
Lake of the Woods4764
Cook2460

Iowa Coronavirus Cases

Data is updated nightly.

Cases: 474151

Reported Deaths: 6785
CountyCasesDeaths
Polk74657729
Linn29194394
Scott24733274
Black Hawk20335358
Woodbury19207244
Johnson17988100
Dubuque15834229
Pottawattamie14276200
Dallas14109108
Story1288551
Warren774296
Cerro Gordo6951110
Webster6950111
Clinton6929101
Des Moines667594
Marshall641885
Muscatine6352113
Wapello5936137
Jasper578279
Lee565689
Sioux565676
Marion508191
Buena Vista491746
Plymouth463487
Henry389847
Jones370861
Washington366856
Benton359257
Bremer357168
Boone350937
Carroll346353
Crawford339347
Mahaska322856
Dickinson301052
Clay279133
Buchanan279039
Jackson273546
Kossuth271873
Hardin270249
Tama264976
Fayette260649
Delaware258546
Cedar249526
Page249328
Wright243645
Hamilton233954
Winneshiek233338
Floyd221845
Harrison217777
Madison216925
Clayton214558
Poweshiek211741
Iowa208029
Butler206638
Cass201557
Jefferson201040
Mills199929
Allamakee194753
Cherokee193844
Lyon192941
Hancock187639
Winnebago186633
Calhoun186116
Appanoose180850
Shelby178439
Louisa171052
Grundy168537
Humboldt167727
Emmet167146
Franklin164628
Mitchell164043
Union162637
Chickasaw159318
Sac157924
Guthrie155434
Montgomery142342
Palo Alto142032
Clarke141328
Keokuk139635
Monroe134335
Howard128222
Ida118641
Greene116315
Davis115225
Lucas113724
Pocahontas111423
Monona108738
Worth10818
Adair105335
Osceola94017
Fremont86111
Van Buren84221
Decatur82612
Taylor79713
Wayne74824
Ringgold67727
Audubon66814
Adams5095
Unassigned380
Rochester
Partly Cloudy
45° wxIcon
Hi: 47° Lo: 37°
Feels Like: 40°
Mason City
Cloudy
42° wxIcon
Hi: 46° Lo: 39°
Feels Like: 33°
Albert Lea
Cloudy
43° wxIcon
Hi: 46° Lo: 37°
Feels Like: 37°
Austin
Cloudy
43° wxIcon
Hi: 47° Lo: 37°
Feels Like: 37°
Charles City
Cloudy
41° wxIcon
Hi: 45° Lo: 40°
Feels Like: 33°
KIMT Radar
KIMT Eye in the sky

Latest Video

Image

Remembering Ted Benda

Image

Century girls' swim team makes it to true team state

Image

Creepy doll cocktail party

Image

Northern Lights Festival postponed

Image

Locally grown onions

Image

Pine Island home destroyed

Image

Full Weather 10/23/2021

Image

FULL Weather 10/22/21

Image

'Nerdinout Con' kicks off at Mayo Civic Center

Image

Ear of Corn tower is people's choice winner

Community Events