Â鶹ӰÊÓ

Skip to main content

U.S. FDA pulls authorization for GSK-Vir's COVID therapy amid rising BA.2 cases

Share

The U.S. health regulator said on Tuesday GlaxoSmithKline GSK.L and Vir Biotechnology's VIR.O antibody therapy was no longer authorized as a COVID-19 treatment, with data suggesting it was unlikely to be effective against the dominant Omicron sub-variant in the country.

The agency pulled its authorization for the therapy, sotrovimab, in much of the U.S. northeast last month.

The highly contagious BA.2 coronavirus sub-variant is estimated to make up about three of every four COVID-19 cases in the United States, according to the latest government data.

GlaxoSmithKline and Vir have said treatment with sotrovimab retains neutralizing activity against the BA.2 sub-variant, but others, including researchers from Columbia University, disagree.

GSK spokeswoman Lyndsay Meyer said on Tuesday as COVID continues to evolve and new variants emerge, the company expects governments and health systems will continue to need a diverse arsenal of vaccine and therapeutic options, and the company will continue to work with them to ensure ongoing access to sotrovimab.

Shares of Vir Biotechnology, which was yet to respond to a Reuters request for comment, fell nearly 10 per cent in afternoon trading.

Last month, the companies said they were preparing a package of data in support of a higher dose for sotrovimab than the currently authorized 500 mg for the BA.2 sub-variant.

The U.S. Food and Drug Administration's move on Tuesday comes as a blow as GlaxoSmithKline and Vir saw high demand for sotrovimab after it became one of the few COVID treatments shown to have worked against the Omicron variant. 

(Reporting by Leroy Leo and Bhanvi Satija in Bengaluru; Editing by Shounak Dasgupta and Vinay Dwivedi)

CTVNews.ca Top Stories

A northern Ontario man is facing a $12,000 fine after illegally shooting a moose near the Batchawan River.

Police have arrested an 18-year-old woman who allegedly stole a Porsche and then ran over its owner in an incident that was captured on video.

A body has been found in the vicinity where a woman went missing on the Ottawa River near Pembroke, Ont. while kayaking Tuesday night, according to the Ontario Provincial Police (OPP).

Local Spotlight

Cole Haas is more than just an avid fan of the F.W. Johnson Wildcats football team. He's a fixture on the sidelines, a source of encouragement, and a beloved member of the team.

Getting a photograph of a rainbow? Common. Getting a photo of a lightning strike? Rare. Getting a photo of both at the same time? Extremely rare, but it happened to a Manitoba photographer this week.

An anonymous business owner paid off the mortgage for a New Brunswick not-for-profit.

They say a dog is a man’s best friend. In the case of Darren Cropper, from Bonfield, Ont., his three-year-old Siberian husky and golden retriever mix named Bear literally saved his life.

A growing group of brides and wedding photographers from across the province say they have been taken for tens of thousands of dollars by a Barrie, Ont. wedding photographer.

Paleontologists from the Royal B.C. Museum have uncovered "a trove of extraordinary fossils" high in the mountains of northern B.C., the museum announced Thursday.

The search for a missing ancient 28-year-old chocolate donkey ended with a tragic discovery Wednesday.

The Royal Canadian Mounted Police is celebrating an important milestone in the organization's history: 50 years since the first women joined the force.

It's been a whirlwind of joyful events for a northern Ontario couple who just welcomed a baby into their family and won the $70 million Lotto Max jackpot last month.