July 21, 2011 — The US Food and Drug Administration (FDA) has approved incobotulinumtoxinA (Xeomin, Merz Aesthetics) for a temporary improvement in the appearance of moderate to severe glabellar (frown) lines, the manufacturer announced today.
The approval of incobotulinumtoxinA is based on the results of 2 multicenter US clinical trials involving 547 healthy adults. In both studies, incobotulinumtoxinA significantly improved the appearance of glabellar lines 30 days after the first injection when compared with placebo, the company said.
Headache was the most common adverse reaction seen in the studies (incidence, ≥2% of patients and greater than placebo).
“Xeomin is a promising new option for both patients and physicians and we are encouraged by the response rates seen in the phase III clinical trials,” said Derek H. Jones, MD, an investigator for the US studies, clinical associate professor of medicine at the University of California–Los Angeles, and director of Skin Care and Laser Physicians in Beverly Hills, California, in a company press release.
IncobotulinumtoxinA is already approved for a temporary improvement in the appearance of glabellar lines in 14 countries in the European Union, including Germany, the United Kingdom, France, Italy, and Spain, under the brand name Bocouture.
It was approved by the FDA in July 2010 for the treatment of cervical dystonia and blepharospasm.
