AbbVie Receives FDA Complete Response Letter for TrenibotulinumtoxinE

AbbVie announced that the U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the company’s Biologics License Application for trenibotulinumtoxinE (TrenibotE), an investigational botulinum neurotoxin under review for aesthetic use in the United States.

According to AbbVie, the FDA’s CRL requests additional information related to manufacturing processes. The agency did not identify any safety or efficacy concerns and did not request additional clinical studies as part of its review. AbbVie said it is confident in its ability to address the FDA’s comments and plans to submit a response in the coming months.

Regulatory reviews of TrenibotE are ongoing in other markets.

About trenibotulinumtoxinE (TrenibotE)

TrenibotE is a first-in-class botulinum neurotoxin serotype E characterized by a rapid onset of action as early as 8 hours after administration (earliest assessment time) and short duration of effect of 2-3 weeks.

The safety and efficacy of TrenibotE are supported by data from over 2,100 patients treated with TrenibotE in the clinical program, which included two pivotal Phase 3 clinical studies evaluating TrenibotE for the treatment of moderate to severe glabellar lines and a Phase 3 open-label safety study.