AbbVie receives CRL from FDA regarding BLA for trenibotulinumtoxinE

AbbVie (ABBV) announced that it received a Complete Response Letter from the U.S. FDA regarding the Biologics License Application for trenibotulinumtoxinE, 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 is confident that it can address the FDA’s comments promptly and expects to submit a thorough response in the coming months. “We strongly believe trenibotulinumtoxinE is an important innovation in botulinum toxin science, with the potential to expand options for patients interested in facial aesthetics,” said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie. “Though disappointed, we remain confident in the strength and integrity of our application, and we are well positioned to respond to the agency’s feedback promptly to support completion of the review.” Regulatory reviews for TrenibotE in other countries are ongoing and progressing as expected.