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# AbbVie Gets ‘Complete Response’ for Neurotoxin Candidate
- URL: https://www.fdaweb.com/abbvie-gets-complete-response-for-neurotoxin-candidate/
- Published: 2026-04-24T12:00:00.000Z
- Updated: 2026-09-14T13:38:02.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5161041

FDA has issued AbbVie a complete response letter for its BLA for trenibotulinumtoxinE, an investigational, fast-acting botulinum toxin intended for aesthetic use. The agency’s letter focused on manufacturing-related issues and did not cite concerns related to safety or efficacy, according to the company. Importantly, FDA did not request any additional clinical studies, a signal that the application’s underlying data package may remain intact.

AbbVie said it plans to respond to the agency’s questions in the coming months and expressed confidence that it can address the manufacturing deficiencies.

TrenibotulinumtoxinE, also known as TrenibotE, is designed as a short-duration neurotoxin, with effects beginning as early as eight hours after injection and lasting roughly two to three weeks. That profile contrasts with longer-acting products currently on the market and could position the therapy as a more flexible option for patients seeking temporary aesthetic treatments.

The application is supported by a clinical program involving more than 2,100 patients, including two Phase 3 trials in moderate-to-severe glabellar lines and an open-label safety study, according to the company.