FDA Issues Complete Response Letter to AbbVie on TrenibotE Application Citing Manufacturing Issues
AbbVie received a Complete Response Letter from the U.S. Food and Drug Administration on June 10, 2026, regarding its Biologics License Application for trenibotulinumtoxinE.
benzinga.comU.S. Food and Drug Administration regarding its Biologics License Application for trenibotulinumtoxinE, known as TrenibotE. The announcement was issued from Spokane, Washington, on June 10, 2026.
TrenibotE is an investigational botulinum neurotoxin serotype E under review for the treatment of moderate to severe glabellar lines. The FDA's feedback focused on manufacturing-process information. The letter did not cite concerns related to clinical safety or efficacy and did not request additional clinical trials.
AbbVie stated it intends to submit a response to the Complete Response Letter in the coming months. Wm. Philip "Phil" Werschler, MD, a board-certified dermatologist in Spokane who served as a clinical trial investigator in the trenibotulinumtoxinE program, described the regulatory process.
He said a Complete Response Letter is the formal way the FDA tells a sponsor what an application still needs before it can be approved. Benzinga reported the details of the FDA letter and AbbVie's planned response.
