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Allergan Aesthetics Receives Positive CHMP Opinion for Boey®

Allergan Aesthetics, a subsidiary of AbbVie and a trailblazer in the field of medical aesthetics, has announced a major milestone. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion regarding the approval of Boey® (trenibotulinumtoxinE) for the temporary amelioration of moderate to severe glabellar lines in adults. If the European Commission gives the nod following this recommendation, Boey® could become the groundbreaking first botulinum neurotoxin serotype E available for adult patients wishing to improve the appearance of frown lines.

The implications of this decision are vast, particularly for patients in the 30 European Economic Area (EEA) countries where the product will be made available, pending the outcome of the regulatory process. The positive opinion is underpinned by robust data from two pivotal Phase 3 trials, M21-500 and M21-508, demonstrating that patients can expect noticeable results as early as eight hours post-treatment, with effects lasting between two to three weeks. This rapid onset of action is a significant advancement in the aesthetics field, aiming to address the psychological impact that glabellar lines can have.

Dr. Roopal Thakkar, Executive Vice President and Chief Scientific Officer at AbbVie, remarked, "The CHMP’s endorsement for Boey® is a reflection of the years of dedicated scientific innovation and clinical effort aimed at advancing botulinum toxin science. We believe that Boey has the potential to provide a uniquely distinguished treatment option for patients still contemplating their options in facial injectables."

The positive CHMP opinion also highlights that the treatment-emergent adverse events associated with Boey® were akin to the occurrences seen in placebo groups. This aspect is crucial as it underscores the safety profile of the intervention, making it a compelling choice for potential users. The absence of significant safety concerns will likely ease patients’ apprehensions regarding the use of injectables.

Allergan Aesthetics has signaled readiness for the commercial launch of Boey®, contingent on final approval from the European Commission. They are also engaged in preparing educational resources for healthcare professionals on the product's appropriate utilization. Additionally, the company is assessing marketing authorization applications in various global regions, thereby pointing towards a wider rollout of this innovative treatment beyond European borders.

Understanding Glabellar Lines

Glabellar lines, often referred to as frown lines, are the vertical lines observed between the eyebrows. Many adults find that the presence of these lines gives an impression of being tired, angry, or worried, which can lead to psychological effects such as decreased self-esteem or increased social anxiety. By addressing glabellar lines, treatments like Boey® aim not only to enhance physical appearance but also to promote emotional well-being.

Establishing itself as a pioneer in the medical aesthetics industry, Allergan Aesthetics consistently seeks to combine innovation with quality customer service. Their expansive portfolio encompasses a range of aesthetic products, including facial injectables, body contouring solutions, skincare, and other advanced medical products.

About AbbVie

AbbVie is committed to discovering and delivering groundbreaking solutions that effectively confront serious health issues. Their focus spans several critical therapeutic areas, notably immunology, neuroscience, and oncology, which, alongside their aesthetic portfolio, aims to make a remarkable difference in people's lives.

For further specifics about Boey® and other offerings from Allergan Aesthetics, visit www.allerganaesthetics.com.