Abbvie Provides Update on Trenibotulinumtoxine Biologics License Application in the U.S

Published: 2026-04-23 17:20:27 ET ABBV

Published on 04/23/2026 at 05:20 pm EDT

AbbVie received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for trenibotulinumtoxinE (TrenibotE), a first-in-class botulinum neurotoxin serotype E with a rapid onset of effect and short duration. In its letter, the FDA requested additional information about manufacturing processes. The CRL does not identify any safety or efficacy concerns for TrenibotE, and does not request additional clinical studies.

AbbVie expects to submit a thorough response in the coming months. Regulatory reviews for TrenibotE in other countries are ongoing and progressing as expected. 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.