Competitive alternatives to Botox continue to sprout up around the world. The newest one is Azzalure, a botulinum toxin Type A muscle relaxant developed for aesthetic use and manufactured by Paris-based Ipsen. It has just recently received marketing approval in France. The marketing approval is for the temporary improvement in the appearance of moderate to severe glabellar lines in adults up to age 65, when the severity of these lines has significant psychological impact on the patient. The approval was based on several clinical trials involving more than 2,600 patients. This is essentially the exact indications that Botox was FDA-approved for in the United States.
Azzalure will be marketed by Galderma, a dermatology company, in France starting this year. The market authorization for Azzalure follows from a recent approval from 15 European countries’ health authorities in January. Since this announcement, three other market approvals for Azzalure have been granted in the United Kingdom, Denmark and Portugal.
There is no available information as to how Azzalure compares to Botox in terms of duration of action, unit dosage, or cost. It is likely that it is similar in its effectiveness and in how long it lasts, given that it is a Type A botulinum derivative. While Azzalure may have market approval in Europe, do not expect to see it here in the United States any time soon. The transition from European CEA approval to FDA approval can be a long and arduous one. The most likely competitor to Botox to appear perhaps this year is Reloxin. (also known as Dysport in most of the rest of the world) It has been around and used much longer and is well into the FDA regulatory process.
While major cosmetic surgery may be down, noninvasive treatments such as Botox, continue to hold steady and may even be increasing despite the economy. Because of their effectiveness, relatively low cost compared to surgery, and no need for any recovery, Botox and injectable fillers offer a quick fix for minor to moderate facial rejuvenation.
Dr. Barry Eppley
Indianapolis, Indiana