FDA OKs Merz' Xeomin for cervical dystonia and blepharospasm; and two generics for Sagent

The US Food and Drug Administration has approved German drugmaker Merz' Xeomin (incobotulinumtoxin A), 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 USA.

"This is an important regulatory milestone for Xeomin and is key to establishing our neurology business in the USA," said Jack Britts, president and chief of Merz Pharmaceuticals in The USA, adding: "We at Merz understand, and are committed to, addressing the complexities of treating and living with these neurological disorders."

The FDA approval of the drug 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 (onabotulinumtoxin A) were included among the data submitted in support of the registration filing in these conditions.