- Data supporting the positive decision demonstrated that patients treated with Alluzience for wrinkles had a rapid onset of effect starting from day one, with improvements lasting up to six months.1
Galderma today announced that Alluzience has completed its European decentralized procedure resulting in a positive decision for the first ready-to-use neuromodulator, a wrinkle relaxing injection, in Europe. National approvals will now take place across the region in line with local processes in each country. Designed for precision, Alluzience is a liquid form of botulinum toxin type A intended for use in adult patients as a treatment to temporarily improve the appearance of moderate to severe glabellar lines (vertical lines between the eyebrows), when the severity of these lines has an important psychological impact on the patient.1
"The introduction of Alluzience marks a new era in treatment innovation for upper facial lines in Europe. Like many aspects of physical appearance, glabellar lines can have a significant impact on patients' confidence and wellbeing. I've heard first-hand that the transition to living and working in a virtual world has only exacerbated these issues.
As the first ready-to-use neurotoxin in Europe, Alluzience is fit for the needs of today; it will allow me to consistently optimize results and deliver patient satisfaction with more precision. Most importantly, it will help people to feel confident in themselves again."
Dr Joanna Czuwara, MD, PhD, Associate Professor, Department of Dermatology, Warsaw Medical University, Poland
As people age, the skin and underlying muscles play a significant role in the emergence of noticeable lines and folds, including glabellar lines between the eyebrows.2 Clostridium botulinum toxin type A (BoNT-A), the active ingredient in Alluzience, is often used to smooth facial lines including glabellar lines.2 All currently approved BoNT-A products (or formulations) in Europe come in powder form and require reconstitution with sodium chloride before use.2 The ready-to-use liquid formulation of Alluzience avoids any calculations and allows for more precision, meaning it has the potential to improve safety and dosing accuracy compared with powder form BoNT-A preparations.2 Alluzience was developed using novel production technologies meaning it is free from human and animal-derived proteins such as human serum albumin and lactose.1
The European Marketing Authorization Application of Alluzience is based on pooled data from two pivotal trials of 372 patients with moderate to severe glabellar lines who were treated with either Alluzience (n=250) or placebo (n=122). These data demonstrated that >50% of patients reported an effect within two to three days, including 23% of patients within one day.1 An effect was demonstrated for up to six months after injection with Alluzience.1 The responder rate at day 29 was significantly higher for patients treated with Alluzience compared to placebo (primary endpoint) (p<0.0001).1
Additionally, patients' level of satisfaction one month following injection showed that 85.2% of the patients receiving Alluzience were either satisfied or very satisfied compared to 9% for placebo patients.1 The majority of adverse reactions reported with Alluzience in clinical trials were of mild to moderate intensity and reversible.1 The most frequently reported adverse reactions were headache and injection site reactions.1
"At Galderma we pride ourselves on developing innovative products that meet today's needs, which is underpinned by our longstanding knowledge and heritage in dermatology. We know how advantageous it is for doctors to have access to a ready-to-use liquid formulation in Alluzience. It's for this reason that today's news is an important milestone for both patients and healthcare professionals."
Alexandre Brennan Head, Global Business Unit for Aesthetics
About Galderma
Galderma is the world's largest independent dermatology company, present in approximately 100 countries. Since our inception in 1981, we have been driven by a complete dedication to dermatology. We deliver an innovative, science-based portfolio of sophisticated brands and services across Aesthetics, Consumer Care and Prescription Medicine. Focused on the needs of consumers and patients, we work in partnership with healthcare professionals to ensure superior outcomes. Because we understand that the skin we're in shapes our life stories, we are advancing dermatology for every skin story.
For more information: www.galderma.com.
About Alluzience(liquid botulinum toxin type A)
Alluzience(liquid botulinum toxin type A) is the first ready-to-use BoNT-A liquid neuromodulator formulation to be introduced in Europe. Alluzience should only be administered by a physician with appropriate qualifications and expertise in this treatment using the required equipment.1 Dosing and treatment intervals depend on assessment of the individual patient's response.1 The treatment interval should be no more frequent than every three months.1 For more information, please see the Summary of Product Characteristics.1
Alluzience is a product under license from Ipsen. Alluzience is a registered trademark of Ipsen. Galderma has an exclusive license from Ipsen to develop, promote and distribute Alluzience in the approved indication in Europe (excluding Czech Republic, Slovakia, Greece, Lithuania, Estonia, Latvia, Hungary).
1 Alluzience Summary of Product Characteristics.
2 Ascher B, Rzany B, Kestemont P, et al. Liquid Formulation of AbobotulinumtoxinA: A 6-Month, Phase 3, Double-Blind, Randomized, Placebo Controlled Study of a Single Treatment, Ready-to Use Toxin for Moderate-to-Severe Glabellar Lines. Aesthet Surg J. 2020;40(1):93-104.
Job code: GL-ALZ-2100026
Date of preparation: June 2021
View source version on businesswire.com: https://www.businesswire.com/news/home/20210611005195/en/
Contacts:
Media Contact
Lauren Starr, Head of Franchise Communications at Galderma
Email: lauren.starr@galderma.com
Phone: +41 79 771 52 45
Justine Brodie, Senior Account Manager at OPEN Health
Email: JustineBrodie@OpenHealthGroup.com
Phone: +44 7342 092 035
