AbbVie Inc. (NYSE:ABBV) shares are down during Friday’s premarket session following a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application for trenibotulinumtoxinE (TrenibotE).

The letter requested additional information about manufacturing processes but did not raise any safety or efficacy concerns.

FDA Rejection Hits AbbVie Wrinkle Drug Filing

The FDA’s CRL does not require additional clinical studies, and AbbVie is confident in addressing the agency’s feedback promptly.

The company expects to submit a thorough response in the coming months, while regulatory reviews for TrenibotE in other countries are ongoing.

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

In April 2025, the U.S.-based large-cap drug maker submitted the FDA application for TrenibotE for moderate to severe glabellar lines (frown lines).

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