IncobotulinumtoxinA approved for glabellar line-related use

July 27, 2011

The FDA has approved the use of incobotulinumtoxinA (Xeomin, Merz Aesthetics) to temporarily improve the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.

San Mateo, CA-The FDA has approved the use of incobotulinumtoxinA (Xeomin, Merz Aesthetics) to improve the appearance temporarily of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adults.

It will be available to physicians in spring 2012.

“The FDA approval of [incobotulinumtoxinA] is a significant milestone for Merz Aesthetics and a promising addition to our entire aesthetics franchise,” said Dennis Condon, president and chief business officer of the company. “We are confident that [incobotulinumtoxinA] will provide patients and physicians with a new option for improving the appearance of glabellar lines.”

The approval is based on the results of two pivotal U.S. clinical trials including a total of 547 healthy adult patients at 16 investigational sites. In both studies, incobotulinumtoxinA significantly improved the appearance of glabellar lines 30 days after the first injection when compared with placebo, according to the company.

IncobotulinumtoxinA is the only botulinum toxin currently approved in the United States that does not require refrigeration before reconstitution, according to the company. The injectable is approved for the same indication in 14 countries in the European Union under a different brand name (Bocouture).