Merz Pharmaceuticals today announced that the FDA has approved Xeomin (incobotulinumtoxinA), a botulinum toxin type A for the treatment of adults with cervical dystonia or blepharospasm. According to an epidemiology study conducted in Rochester, Minnesota, the prevalence of focal dystonia, which includes cervical dystonia and blepharospasm, is estimated at 295 per million people in the U.S.
“This is an important regulatory milestone for XEOMIN and is key to establishing our neurology business in the U.S.,” said Jack Britts, President and CEO of Merz Pharmaceuticals, LLC. “We at Merz understand, and are committed to, addressing the complexities of treating and living with these neurological disorders.” The FDA approval of XEOMIN is based on the results of two pivotal U.S.
clinical trials involving adult patients diagnosed with either cervical dystonia or blepharospasm. Additionally, active comparator studies conducted in Europe evaluating XEOMIN versus Botox (onabotulinumtoxinA) were included among the data submitted in support of the registration filing in these conditions.
XEOMIN is the only botulinum toxin that does not require refrigeration prior to reconstitution. Merz believes this may simplify product distribution and storage, and help ensure product integrity at the time of injection. XEOMIN will be available in 50-unit and 100-unit vials allowing dosing flexibility for administration.