logo
  

FDA Pulls Emergency Use Authorization For Lilly's COVID-19 Antibody Drug

The U.S. Food and Drug Administration has pulled its emergency-use authorization for bebtelovimab, a COVID-19 antibody co-developed by Eli Lilly & Co. (LLY) and AbCellera Biologics Inc. (ABCL), after determining that the drug is not expected to neutralize the two new Omicron subvariants BQ.1 and BQ.1.1.

The drug received the authorization from the FDA in February.

The FDA on Wednesday said data from the Centers for Disease Control and Prevention published last week estimates that the combined proportion of COVID-19 cases caused by the Omicron BQ.1 and BQ.1.1 subvariants to be above 57% nationally, and already above 50% in all individual regions.

"Given that a COVID-19 infection is likely to be caused by a non-susceptible SARS-CoV-2 variant, and consistent with the terms and conditions of the Letter of Authorization, bebtelovimab is not currently authorized for emergency use in any U.S. region at this time," the FDA said.

According to the FDA, Eli Lilly and its authorized distributors have paused commercial distribution of bebtelovimab until further notice by the Agency. Additionally, the Administration for Strategic Preparedness and Response has paused the fulfillment of any pending requests under its Bebtelovimab Product Replacement Initiative.

For More Such Health News, visit rttnews.com

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Integrated energy company Chevron reported Friday that profit for the fourth quarter increased 25 percent from last year, reflecting 17 percent revenue growth amid higher realizations and higher margins on refined product sales. Adjusted earnings per share missed analysts' estimates, while quarterly revenues topped it. Reno, Nevada-based ZLINE Kitchen and Bath has expanded its recall of gas ranges citing serious risk of injury or death from carbon monoxide poisoning, the U.S. Consumer Product Safety Commission announced. The recall now includes about 30,000 units of ZLINE gas ranges, including about 28,000 units... The Food and Drug Administration's independent advisory committee unanimously recommended replacing the current original COVID vaccines used in the U.S. for primary shots with new bivalent omicron shots authorized as boosters, reports said. The committee also considered the proposal for annual COVID vaccination, however, didn't vote on it.
Follow RTT