Earlier today, Merz Aesthetics announced the US-FDA approval of XEOMIN® (incobotulinumtoxinA). XEOMIN is used in adult patients for temporary improvement in the appearance of moderate to severe glabellar lines, or frown lines between the eyebrows.
President and Chief Business Officer of Merz Aesthetics Inc., Dennis Condon, said that “The FDA approval of XEOMIN is a significant milestone for Merz Aesthetics and a promising addition to our entire aesthetics franchise.” He added, “We are confident that XEOMIN will provide patients and physicians with a new option for improving the appearance of glabellar lines.”
Derek H Jones, MD, an investigator for the XEOMIN US study; Clinical Associate Professor of Medicine at the University of California in Los Angeles, CA; and Director of Skin Care and Laser Physicians in Beverly Hills, CA; said that “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.”
XEOMIN has received FDA approval based on results obtained from 2 pivotal clinical trials in the US comprising 547 healthy adult patients from 16 investigational sites. Compared to placebo in both studies, XEOMIN drastically improved the appearance of glabellar lines within 30 days of the first injection. The only botulinum toxin –XEOMIN– that is currently approved in the US does not require refrigeration prior to reconstitution.
Nearly 14 countries in the European Union (EU) including Germany, the United Kingdom, France, Italy, and Spain have approved XEOMIN under the brand name BOCOUTURE® for temporary improvement in the appearance of glabellar lines.
Physicians all over the nation will be made available with XEOMIN in the spring of 2012.