Xeomin receives FDA approval

The US Food and Drug Administration (FDA) has approved Merz Pharmaceutical's Xeomin (incobotulinumtoxinA), a botulinum toxin type A for the treatment of adults with cervical dystonia or blepharospasm.

Approval was based on the results of two pivotal US clinical trials involving adult patients diagnosed with either cervical dystonia or blepharospasm. Active comparator studies conducted in Europe, which evaluated Xeomin versus Botox (onabotulinumtoxinA), were also included in the data submitted in support of the registration filing in these conditions.

Jack Britts, president and CEO of Merz Pharmaceuticals commented that this is an important regulatory milestone for Xeomin and is key to establishing the company's neurology business in the US.

"We at Merz understand, and are committed to, addressing the complexities of treating and living with these neurological disorders," Britts said.

Xeomin is the only botulinum toxin that does not require refrigeration prior to reconstitution. Merz believes this attribute will simplify product distribution and storage, and help ensure product integrity at the time of injection.

The drug will be available in 50-unit and 100-unit vials, allowing dosing flexibility for administration.