AbbVie FDA Rejects Wrinkle Treatment Over Manufacturing

AbbVie announced the U.S. FDA declined approval of its experimental wrinkle treatment, TrenibotulinumtoxinE, citing manufacturing concerns.
The FDA requested additional manufacturing information but found no safety or efficacy issues and did not ask for further clinical studies.
The drug, a botulinum toxin serotype E, showed 8‑hour onset and 2‑3 week duration in Phase 3 trials with over 2,100 patients.
AbbVie plans to respond to FDA comments in coming months while continuing regulatory reviews of the treatment in other countries.