GREENSBORO, N.C. — Merz Pharmaceuticals has received Food and Drug Administration approval for Xeomin (incobotulinumtoxinA), a botulinum toxin type A for the treatment of adults with cervical dystonia or blepharospasm.
"This is an important regulatory milestone for Xeomin and is key to establishing our neurology business in the U.S.," stated Jack Britts, president and chief executive officer of Merz Pharmaceuticals. "We at Merz understand and are committed to addressing the complexities of treating and living with these neurological disorders."
Dystonias are neurological movement disorders in which sustained muscle contractions cause twisting and repetitive movements or abnormal postures, Merz explained. These movements, which are involuntary and sometimes painful, may affect a single muscle (focal); a group of muscles such as those in the arms, legs or neck (segmental); or the entire body (generalized). Symptoms can be mild or severe, and dystonias may be markedly disabling.
Although dystonia is thought to be rare, it is possibly undiagnosed or misdiagnosed due to lack of specific clinical criteria. While focal dystonia, such as blepharospasm or cervical dystonia, can affect people at any age, most people first experience symptoms in middle age.
According to an epidemiology study conducted in Rochester, Minn., the prevalence of focal dystonia, which includes cervical dystonia and blepharospasm, is estimated at 295 per million people in the United States.
Merz said the FDA’s 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, the company reported.
Merz noted that Xeomin is the only botulinum toxin that doesn’t require refrigeration before reconstitution. The company said it believes this may simplify product distribution and storage, as well as 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.
