AbbVie (NYSE:ABBV), a prominent player in the biotechnology industry with a market capitalization of $313.2 billion, has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for its new product, trenibotulinumtoxinE (TrenibotE), aimed at treating moderate to severe glabellar lines, commonly known as frown lines. The company announced the submission today, positioning TrenibotE as a potential first-in-class botulinum neurotoxin serotype E with a rapid onset of action and a shorter duration of effect.
The application is backed by data from a clinical program involving over 2,100 patients. The program included two pivotal Phase 3 clinical studies and a Phase 3 open-label safety study, all of which met their primary and secondary endpoints. TrenibotE demonstrated a swift onset of action, with effects observed as early as 8 hours after administration, and an efficacy duration of 2-3 weeks. The safety profile was comparable to placebo, even after up to three consecutive treatments.
Darin Messina, Ph.D., senior vice president of aesthetics R&D at AbbVie, expressed that TrenibotE’s differentiated clinical profile offers patients a faster onset and shorter treatment duration, which could be particularly appealing for those new to facial aesthetic treatments. The product is designed to address concerns of looking unnatural, a common barrier cited by new patients considering neurotoxin use for aesthetic purposes.
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