January 24, 2022

Eli Lilly Covid-19 Antibody Drug Shipments Paused Over Variant Concerns

U.S. health officials have paused the distribution of two

Eli Lilly

LLY -1.18%

& Co. Covid-19 monoclonal antibody treatments because of data showing that they aren’t effective against virus variants that are becoming increasingly common across the country.

The Department of Health and Human Services said Friday that it is immediately pausing all distribution of bamlanivimab and etesevimab together, as well as etesevimab alone to be paired with existing supplies of bamlanivimab, in the U.S. until further notice.

Health administrators cited analyses that found that the two antibody treatments together weren’t effective against two variants: the Gamma variant, first identified in Brazil, and the Beta variant, first identified in South Africa.

These variants account for more than 11% of Covid-19 cases, a share that is growing, according to the Centers for Disease Control and Prevention.

Distribution of the antibody treatments was already paused because of concerns regarding their effectiveness with the variants in at least nine states including Rhode Island, Arizona, California, Florida, Washington and Massachusetts.

Lilly said that the company is working with governments and regulators to ensure antibodies are available to appropriate patients as variants continue to evolve.

The move comes after Lilly in April asked U.S. health regulators to revoke the authorization for use of bamlanivimab alone because of its lack of potency against some strains of the virus.

At the time the drugmaker said it would focus on distributing a drug cocktail containing bamlanivimab and etesevimab, citing studies that it would neutralize more of the variants when given together. The Food and Drug Administration granted the request.

Instead of the two treatments produced by Lilly, the FDA recommends healthcare providers use

Regeneron Pharmaceuticals Inc.’s

REGEN-COV, which has been approved for use since last November, and

Vir Biotechnology Inc.

and

GlaxoSmithKline

PLC’s sotrovimab, which was approved in May.

Both monoclonal antibody therapies were approved for the same use as Lilly’s treatments, and U.S. health authorities found that those treatments are likely to work in spite of the two variants.

The move reveals how emerging variants could pose challenges to both treatments and vaccines. The U.S. is racing to vaccinate Americans as more variants, including the highly transmissible Delta variant, gain a foothold in the country.

The Delta strain, which was first identified in India, could become the dominant strain in the U.S. in the coming weeks, according to researchers.

Monoclonal antibodies are engineered proteins that mimic the immune system’s response to fight off viruses. Lilly’s first treatment, bamlanivimab, was the first to receive emergency-use authorization in November for use in patients with earlier-stage Covid-19 who aren’t hospitalized but are at high risk. In February, the FDA authorized the combination of bamlanivimab with etesevimab, administered together for patients who are at risk of worsening to severe Covid-19, including those with certain medical conditions or who are ages 65 and over.

Meanwhile,

Roche Holding AG

announced Friday that the FDA has authorized the company’s drug Actemra for treatment of adults and children ages 2 and older who are hospitalized for Covid-19 and are receiving corticosteroids and require oxygen or breathing support.

Write to Laura Cooper at laura.cooper@wsj.com

Copyright ©2020 Dow Jones & Company, Inc. All Rights Reserved. 87990cbe856818d5eddac44c7b1cdeb8

Related Posts

Colonial Pipeline Missed Requested Security Review Before Hack

May 26, 2021

May 26, 2021

Colonial Pipeline Co. last year didn’t undergo a requested federal security review of its facilities and was in the process...

Where Google’s Advertising Chief Searches for Insight

June 12, 2021

June 12, 2021

A week before Lorraine Twohill applied to engineering school in her native Ireland, she found herself reviewing a brochure about...

What Happens When Mental-Health Issues Get in the Way of Work

June 3, 2021

June 3, 2021

Naomi Osaka did something this week that would be unthinkable in many workplaces. Citing her struggles with depression and social...

Tesla Shareholder Panasonic Sells Stake for $3.6 Billion

June 25, 2021

June 25, 2021

TOKYO— Tesla Inc.’s leading battery supplier is no longer a Tesla shareholder. Panasonic Corp. said Friday it has sold its...

Retailers Race to Keep Kayaks and TVs in Stock

May 27, 2021

May 27, 2021

Big retail chains such as Dick’s Sporting Goods Inc. and Best Buy Co. say they are rushing to have enough...

Carlos Ghosn, Stuck in Beirut, Says He Is Ready for Questioning by French Investigators

May 24, 2021

May 24, 2021

BEIRUT—Fugitive ex-auto executive Carlos Ghosn said he is content with his life in Lebanon and ready for his next challenge—dealing...

Americans’ Hunger for the World’s Goods Drives Global Recovery

June 28, 2021

June 28, 2021

A gusher of money is spilling out from the U.S. economy and rippling around the world, driving the global recovery...

Goat Group, Parent of Sneaker Marketplace, Valued at $3.7 Billion in Latest Funding Round

June 24, 2021

June 24, 2021

Goat Group, parent company of an online marketplace for sneakerheads, said it has raised $195 million through private investors to...

GameStop’s Chief Operating Officer Departs

October 29, 2021

October 29, 2021

GameStop Corp.’s chief operating officer, Jenna Owens, has left the company, less than a year after joining. GameStop didn’t give...

Chewy CFO Says Broader Product Range Bearing Fruit in Higher Earnings

June 22, 2021

June 22, 2021

Chewy Inc.’s finance chief said recent efforts to expand the pet retailer’s product range are paying off in the form...

Supreme Court Declines to Lift National Eviction Moratorium

June 30, 2021

June 30, 2021

WASHINGTON—A divided Supreme Court on Tuesday declined to lift a national moratorium on the eviction of tenants who have fallen...

What Investors Can Learn From the History of Inflation

June 21, 2021

June 21, 2021

Senior citizens’ march to protest inflation, Chicago, Illinois, 1973. Image courtesy John White/US National Archives. (Photo via Smith Collection/Gado/Getty Images)....

Commodity Price Surges Add to Inflation Fears

June 7, 2021

June 7, 2021

The run-up in commodity prices is casting a cloud over the global economic recovery, slamming vulnerable businesses and households and...

Amazon’s Planned Purchase of MGM to Be Reviewed by FTC

June 22, 2021

June 22, 2021

WASHINGTON—The Federal Trade Commission will be the agency to review Amazon. AMZN 1.41% com Inc.’s proposed acquisition of Hollywood studio...

In Apple Antitrust Trial, Judge Signals Interest in Railroad, Credit-Card Monopoly Cases

May 25, 2021

May 25, 2021

The future of digital commerce on your iPhone could be influenced by how courts resolved questions about market control following...