AbbVie Seeks FDA Approval for TrenibotE to Treat Glabellar Lines

AbbVie, a prominent pharmaceutical company, has recently submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for their new product, TrenibotE. This product is designed to treat moderate to severe glabellar lines (the vertical lines between the eyebrows) and is characterized by its rapid action and shorter duration of effectiveness compared to current options on the market. TrenibotE, a first-in-class botulinum neurotoxin serotype E, has demonstrated an onset of action as soon as eight hours after administration and maintains its effect for approximately two to three weeks.

Darin Messina, Ph.D., senior vice president of aesthetics research and development at AbbVie, remarked on the potential of TrenibotE to transform the landscape of aesthetic toxin treatments, especially for new patients entering the facial aesthetics market. The product's rapid onset and shorter treatment duration may alleviate potential patients’ concerns about looking unnatural, which is a significant barrier to initiating neurotoxin treatments for aesthetic purposes.

If TrenibotE is approved, it would become the first neurotoxin of its kind available to patients, offering a unique option for those interested in facial aesthetic treatments. The BLA submission to the FDA is backed by data obtained from over 2,100 patients who were part of the clinical program. This program encompassed two pivotal Phase 3 clinical studies (M21-500 and M21-508) that evaluated TrenibotE for treating moderate to severe glabellar lines, as well as a Phase 3 open-label safety study (M21-509).

The clinical trials achieved all primary and secondary endpoints, highlighting the rapid onset of action and the observed efficacy duration of two to three weeks. Importantly, the safety profile of TrenibotE was comparable to a placebo, even when administered as a single treatment or in up to three consecutive treatments. The company had previously shared the topline data from these pivotal studies, which further supports the product's safety and efficacy.

Dr. Cheryl Burgess, a lead clinical investigator in one of the Phase 3 studies, emphasized how TrenibotE could address the barrier of patients fearing unnatural outcomes from medical aesthetics treatments. With its rapid onset and short duration, TrenibotE could empower patients to explore aesthetics treatments with greater confidence.

This submission represents a significant step forward for AbbVie and its subsidiary, Allergan Aesthetics, which is known for developing and marketing a wide array of aesthetics brands and products. The company is committed to providing innovative solutions, education, and exceptional service in the field of aesthetics.

AbbVie is dedicated to discovering and delivering innovative medicines and solutions for serious health issues and addressing medical challenges. Their work spans various therapeutic areas, including immunology, oncology, neuroscience, and eye care, with a significant focus on products and services in the Allergan Aesthetics portfolio. If approved, TrenibotE would add to their portfolio of offerings in the facial aesthetics category, providing new options for patients and further establishing AbbVie's position in the aesthetics market.