U.S. FDA authorizes new COVID-19 monoclonal antibody that works against Omicron variant

Jen Christensen

CNNDigital

Contact

Published Friday, February 11, 2022 8:49PM EST

https://imasdk.googleapis.com/js/core/bridge3.498.1_en.html#goog_1922717096

Volume 90%

Biden: U.S. will offer 1 billion COVID-19 tests

NOW PLAYING

U.S. President Joe Biden says his government is doubling their order of at-home COVID-19 free tests to a billion, up from 500 million.

CTV National News: Record-high cases in the U.S.

NOW PLAYING

Omicron drove cases in America to record highs over the holidays, and the variant is already crippling everyday life in the country.

‘Still a bit dangerous’: Dr. Pirzada

NOW PLAYING

Dr. Pirzada on the CDC’s recommendation to have shorter isolation times for people who have tested positive for COVID-19.

U.S. sets new daily high for COVID-19 cases

NOW PLAYING

The U.S. logged its highest single-day total of new COVID-19 cases on Tuesday, with 441,278 infections.

CTV National News: New CDC recommendations

NOW PLAYING

U.S. health officials cut isolation restrictions for Americans with COVID-19 from 10 to five days. Richard Madan has the details.

U.S. President Joe Biden on the Omicron variant

NOW PLAYING

U.S. President Joe Biden delivered a message on America’s fight against COVID-19, urging people to get vaccinated and tested.

Biden to deliver speech on rapid test plans

NOW PLAYING

The Washington Post’s Dan Diamond says he expects Biden’s speech to take on a more sombre tone as millions of Americans remain unvaccinated.

CTV National News: Biden to reveal Omicron plan

NOW PLAYING

The Biden administration is expected to reveal a plan to combat the Omicron while sports events are postponed. Richard Madan reports.

CTV National News: Cases surge in the U.S.

NOW PLAYING

The U.S. is dealing with a surge of COVID-19 cases and hospitalizations not seen since early 2021. Tom Walters reports.

Booster shot needed for optimal protection: Fauci

NOW PLAYING

Dr. Anthony Fauci says that data shows if you want to be ‘optimally protected, you really should get a booster’ shot of a COVID-19 vaccine.

Minister of Transport: ‘No plans’ to change current testing requirements with U.S

NOW PLAYING

Omar Alghabra shares an update on what Canadians can expect at the border as the Omicron variant surfaces.

CTV National News: New travel rules

NOW PLAYING

The U.S. is enacting a new rule requiring all inbound travellers to get an antigen test 24 hours before their flight. Glen McGregor explains

Next

SHARE:

https://platform.twitter.com/widgets/tweet_button.4e067713e19d4fff483536ddc4df18b9.en.html#dnt=false&id=twitter-widget-0&lang=en&original_referer=https%3A%2F%2Fwww.ctvnews.ca%2Fhealth%2Fcoronavirus%2Fu-s-fda-authorizes-new-covid-19-monoclonal-antibody-that-works-against-omicron-variant-1.5778708&size=m&text=U.S.%20FDA%20authorizes%20new%20COVID-19%20monoclonal%20antibody%20that%20works%20against%20Omicron%20variant&time=1644701617486&type=share&url=https%3A%2F%2Fwww.ctvnews.ca%2Fhealth%2Fcoronavirus%2Fu-s-fda-authorizes-new-covid-19-monoclonal-antibody-that-works-against-omicron-variant-1.5778708&via=CTVNewsReddit

https://www.facebook.com/plugins/share_button.php?app_id=404047912964744&channel=https%3A%2F%2Fstaticxx.facebook.com%2Fx%2Fconnect%2Fxd_arbiter%2F%3Fversion%3D46%23cb%3Dfe309657a02908%26domain%3Dwww.ctvnews.ca%26is_canvas%3Dfalse%26origin%3Dhttps%253A%252F%252Fwww.ctvnews.ca%252Ff623035e4f6a84%26relation%3Dparent.parent&container_width=64&href=https%3A%2F%2Fwww.ctvnews.ca%2Fhealth%2Fcoronavirus%2Fu-s-fda-authorizes-new-covid-19-monoclonal-antibody-that-works-against-omicron-variant-1.5778708&layout=button_count&locale=en_US&sdk=joey&size=small

The U.S. Food and Drug Administration has authorized a new monoclonal antibody treatment that seems to work against the Omicron variant of the virus that causes COVID-19.

Monoclonal antibodies are lab-made proteins that mimic the immune system’s ability to fight harmful pathogens like the coronavirus. Bebtelovimab, made by Eli Lilly and Company, is a monoclonal antibody given through intravenous injection.

Coronavirus Coverage

Tracking every case of COVID-19 in Canada

‘Living with the virus’: Feds outline what that should look like

Changes to COVID-19 border measures to be announced next week

Pandemic travel: Here’s what experts say you need to know before you go

Study: COVID-19 booster effectiveness wanes but remains strong

Doug Ford says plan in works to remove Ontario’s vaccine passport system

Conservatives call for blockades to end, pushing feds to end COVID-19 mandates

Manitoba ending all COVID-19 restrictions by March 15

Nearly $12 million in CERB payments sent to applicants with foreign addresses

Rapid tests less sensitive to Omicron variant, but Ontario science table says new swab method can help

Doctors and tourism industry calling on Ottawa to end COVID-19 testing requirements

Denmark officials see no reason to give more COVID-19 vaccines

COVID-19 curves: Compare Canada and other key nations

Full coverage at CTVNews.ca/Coronavirus

On Thursday, the Department of Health and Human Services announced that it had purchased 600,000 treatment courses of the treatment. HHS is set to get half of the contract in February and the rest in March. The contract also includes an option to buy 500,000 more courses. The contract is worth at least US$720 million, according to Eli Lilly.

Bebtelovimab can be used to treat people 12 and older who have mild to moderate COVID-19 and are at high risk of a severe form of the disease or for whom other treatment options aren’t accessible or clinically appropriate. It is not authorized for hospitalized patients or those who need oxygen therapy.

Lab tests showed that the treatment seems to work against Omicron, including the BA.2 subvariant.

In a trial with people who were at a low-risk of severe illness, the treatment reduced the time someone with Covid-19 had symptoms, compared with people who did not use it. The group that got bebtelovimab also saw a reduced viral load five days after treatment.

“With the emergence of variants such as Omicron, treatment options remain limited. Lilly is pleased to provide another treatment option to help address the ongoing needs of patients and health care providers who continue to battle this pandemic,” Dr. Daniel Skovronsky, Lilly’s chief scientific and medical officer and president of Lilly Research Laboratories, said in a statement.

Possible side effects of bebtelovimab include reaction at the site of the infusion, nausea and vomiting. With other monoclonal antibody treatments, scientists have noticed rare but serious events including anaphylaxis, infusion-related reactions and hypersensitivity, and these things could also happen with bebtelovimab, the FDA said.

“Today’s action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,” Dr. Patrizia Cavazzoni, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.”

The FDA limited the use of Regeneron’s monoclonal antibody treatment and Eli Lilly’s earlier versions of these treatments in January because they no longer seemed to work against the Omicron variant, which has been the dominant circulating strain for several weeks and now accounts for all new cases in the US. Those treatments had targeted a part of the virus that had changed with Omicron.

Health experts have said they are cautiously optimistic about the pandemic’s trajectory in part because the country has access to more treatments, like monoclonal antibodies, than ever.

Sotrovimab, a monoclonal treatment made by GlaxoSmithKline and Vir Biotechnology, is still thought to work against the Omicron variant. The U.S. Army has struck an $855 million deal with AstraZeneca for Evusheld, an antibody cocktail that also seems to work against Omicron.

RELATED IMAGES

SHARE:

https://platform.twitter.com/widgets/tweet_button.4e067713e19d4fff483536ddc4df18b9.en.html#dnt=false&id=twitter-widget-1&lang=en&original_referer=https%3A%2F%2Fwww.ctvnews.ca%2Fhealth%2Fcoronavirus%2Fu-s-fda-authorizes-new-covid-19-monoclonal-antibody-that-works-against-omicron-variant-1.5778708&size=m&text=U.S.%20FDA%20authorizes%20new%20COVID-19%20monoclonal%20antibody%20that%20works%20against%20Omicron%20variant&time=1644701617488&type=share&url=https%3A%2F%2Fwww.ctvnews.ca%2Fhealth%2Fcoronavirus%2Fu-s-fda-authorizes-new-covid-19-monoclonal-antibody-that-works-against-omicron-variant-1.5778708&via=CTVNewsReddit

https://www.facebook.com/plugins/share_button.php?app_id=404047912964744&channel=https%3A%2F%2Fstaticxx.facebook.com%2Fx%2Fconnect%2Fxd_arbiter%2F%3Fversion%3D46%23cb%3Df377ac68e4b41a4%26domain%3Dwww.ctvnews.ca%26is_canvas%3Dfalse%26origin%3Dhttps%253A%252F%252Fwww.ctvnews.ca%252Ff623035e4f6a84%26relation%3Dparent.parent&container_width=64&href=https%3A%2F%2Fwww.ctvnews.ca%2Fhealth%2Fcoronavirus%2Fu-s-fda-authorizes-new-covid-19-monoclonal-antibody-that-works-against-omicron-variant-1.5778708&layout=button_count&locale=en_US&sdk=joey&size=small

Report an errorEditorial standards and policiesWhy you can trust CTV News

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s