FDA Approves sBLA of incobotulinumtoxinA for Blepharospasm

MAY 13, 2019
Cecilia Pessoa Gingerich
FDA, The US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for incobotulinumtoxinA (Xeomin), expanding its indication to include treatment for blepharospasm (involuntary blinking) in adults.

Blepharospasm can be accompanied by symptoms including excessive blinking, light sensitivity, dry eyes, eye irritation, and watering eyes.

“Merz is proud to offer a first-line treatment option for blepharospasm, a devastating condition that has no cure and affects up to 50,000 patients in the US,” said Kevin O’Brien, Vice President and US Head of Neurosciences, Merz.

The FDA’s decision to approve the sBLA was supported by data from a phase 3, double-blind, placebo-controlled trial. The trial included 61 treatment-naïve patients with blepharospasm. Patients had a baseline Jankovic Rating Scale (JRS) Severity subscore of at least 2 and were considered treatment-naïve if at least 12 months had passed since their last toxin treatment.

The primary endpoint was change from baseline in JRS Severity subscore at 6 weeks after the incobotulinumtoxinA injection. The results demonstrated significant improvement compared to placebo with a difference in scores of -1.2 (P = .0004).

Safety results were in line with previous studies of incobotulinumtoxinA. The incobotulinumtoxinA Prescribing Information includes a boxed warning about the spread of toxin effect, which can include symptoms such as asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and breathing difficulties. These symptoms have been reported as occurring in the hours to weeks following a treatment injection.

IncobotulinumtoxinA was first approved by the FDA in 2010 and now has indications for chronic sialorrhea (excessive drooling), upper limb spasticity, cervical dystonia, and glabellar lines, in addition to blepharospasm.

“This milestone, along with the July 2018 approval of Xeomin for the treatment of chronic sialorrhea (drooling) in adults, reinforces our commitment to providing comprehensive care for patients living with movement disorders,” said O’Brien.

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