AbbVie has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for its experimental product trenibotulinumtoxinE (TrenibotE), seeking approval for use in the treatment of moderate to severe glabellar lines.
The submission includes clinical data involving over 2,100 participants who were administered TrenibotE during a multi-phase clinical development programme.
This includes two Phase 3 trials and a separate open-label Phase 3 safety study. All studies met their respective primary and secondary endpoints, establishing safety and efficacy benchmarks for the product.
AbbVie aesthetics R&D senior vice president Darin Messina said: “The submission provides evidence of TrenibotE’s differentiated clinical profile to offer patients an opportunity to experience a faster onset and shorter treatment duration as an introduction to a neurotoxin.
“TrenibotE has the potential to transform the aesthetic toxin treatment landscape for new patients interested in the facial aesthetics category.”
TrenibotE is being positioned as a serotype E botulinum neurotoxin, intended for patients considering aesthetic neurotoxin treatments for the first time.
According to AbbVie, fear of unnatural appearance remains a commonly cited reason for delaying cosmetic neurotoxin procedures. TrenibotE is designed to offer a shorter duration of effect and rapid onset, enabling a trial experience for patients prior to committing to longer-lasting treatments such as BOTOX Cosmetic.
Clinical trial results indicated that the therapeutic effect of TrenibotE could be observed as early as eight hours following administration, which is the earliest timepoint evaluated in the studies.
The observed efficacy persisted for a duration of two to three weeks. Reported treatment-emergent adverse events were consistent with placebo, whether given as a single administration or in repeated doses across three cycles.
AbbVie had previously disclosed topline results from the two pivotal Phase 3 trials. The company’s move to submit the BLA marks the next step in seeking market authorisation from US regulators for this formulation, which could become the first serotype E botulinum toxin approved for aesthetic indications.
In a separate regulatory development this month, AbbVie also announced that the European Commission has approved RINVOQ (upadacitinib) 15mg for the treatment of adult patients with giant cell arteritis (GCA).
RINVOQ is now authorised for use across the European Union as well as in Iceland, Liechtenstein, and Norway. It is currently the only oral JAK inhibitor cleared in those regions for GCA treatment in adults.
