Merz Aesthetics Inc today announced that the FDA has approved Xeomin (incobotulinumtoxinA) for the temporary improvement in the appearance of moderate to severe glabellar lines in adult patients.
The approval of Xeomin is based on the results of two pivotal U.S. clinical trials involving 16 investigational sites and included 547 healthy adult patients. In both studies, Xeomin significantly improved the appearance of glabellar lines 30 days following the first injection, when compared to placebo. Xeomin is the only botulinum toxin currently approved in the U.S. that does not require refrigeration prior to reconstitution.
Xeomin is approved for the 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 Boucouture.
Xeomin will be available nationwide to physicians in the spring of 2012.
"The FDA approval of Xeomin is a significant milestone for Merz Aesthetics and a promising addition to our entire aesthetics franchise," says Dennis Condon, President and Chief Business Officer of Merz Aesthetics. "We are confident that Xeomin will provide patients and physicians with a new option for improving the appearance of glabellar lines."
"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 Xeomin US study, Clinical Associate Professor of Medicine at the University of California in Los Angeles, and Director of Skin Care and Laser Physicians in Beverly Hills, Calif.
[Source: Digital Journal]