Azzalure has received the UK approval for 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, 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. Azzalure will come in a very easy to use formulation with a customized dosage that is specifically designed to better meet the aesthetic needs of the patient, the two companies said.
This market authorization for Azzalure follows the collective green light from 15 European countries’ health authorities and is one of the several licenses Galderma and Ipsen anticipate in Europe in 2009. The treatment will be commercially available in the UK by the end of the second quarter 2009.
Larry Potgieter, Galderma’s regional director for UK and Northern Europe, said: “Azzalure’s marketing authorization is an important event for corrective and aesthetic patients as Galderma develops its distribution in the UK. Azzalure is the latest product in our expanding range of dermatology treatments and emphasises our commitment to the future of dermatology.”