Ipsen’s Azzalure Approved In Spain For Aesthetic Use

Galderma and Ipsen have announced that Azzalure (botulinum toxin type A manufactured by Ipsen), a local muscle relaxant specifically developed for aesthetic use, has received a marketing authorization in Spain from the Spanish Medicines and Healthcare products Agency (AEMPS). Azzalure is aimed at the temporary improvement in the appearance of moderate to severe glabellar lines seen at the frown, in adult men and women aged 65 years and under.

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 be available in easy to use customised dosage that is specifically designed to better meet the aesthetic needs of the patient, said the company.

The treatment will be commercially available in Spain by the 4th quarter 2009. Azzalure is commercially available in the UK, France, Germany and the Nordic countries.

Francisco Javier Gonzalez, general manager for Spain and Portugal, at Galderma, said: “The marketing authorisation of Azzalure is a great milestone for corrective and aesthetic patients as Galderma develops its distribution in Spain. Patients can look forward to benefiting from Galderma’s years of experience in dermatology, and our commitment to providing the highest standards of medical education and training to healthcare professionals. Azzalure is the latest product in our expanding range of dermatology treatments and emphasises our commitment to the future of dermatology.”