Azzalure approved in Spain for Aesthetic Use

Azzalure will be marketed in Spain by Glderma. The approval process includes 15 countries in Europe.

Galderma, the leading pharmaceutical company in dermatology, and Ipsen (Euronext: IPN), an international innovation-driven specialty pharmaceutical group, today announced that Azzalure® (botulinum toxin type A manufactured by Ipsen), a local muscle relaxant (similiar to BOTOX) specifically developed for aesthetic use, has received a marketing authorization in Spain from the Spanish Medicines and Healthcare products Agency (AEMPS) for the temporary improvement in the appearance of moderate to severe glabellar lines seen at the frown (vertical lines between the eyebrows), in adult men and women aged 65 years and under, when the severity of these lines has an important psychological impact on the patient.

The approval was based on several clinical trials involving more than 2,600 patients, which confirmed the safety and efficacy of Azzalure®. This new treatment is adapted from Dysport (botulinum toxin type-A), which is already marketed by Ipsen for therapeutic indications and has a 20-year long history of product consistency and safety. Azzalure® will come in a very easy to use customized dosage that is specifically designed to better meet the aesthetic needs of the patient.

Azzalure is already available in the UK, France, Germany and the Nordic countries.

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