PHILADELPHIA — The US Food and Drug Administration (FDA) has approved broadening the indication for incobotulinumtoxinA (Xeomin, Merz Pharmaceuticals) as first-line therapy for blepharospasm in adult patients, the manufacturer has announced.
Benign essential blepharospasm (BEB) causes involuntary and excessive closure of the eyelids. The intramuscular injectable drug was already indicated for patients with BEB who have been previously treated with onabotulinumtoxinA (Botox). However, based on results from a new phase 3 trial, the FDA gave approval today to the supplemental Biologic License Application as a first-line treatment in patients who are botulinum toxin-naïve.
As reported by Medscape Medical News, results from the phase 3 trial were presented at the recent American Academy of Neurology (AAN) 2019 Annual Meeting.
"Now we know that if a patient has blepharospasm, this is an option and incobotulinumtoxin-type A can be used right off the bat," Fernando L. Pagan, MD, professor and vice chair of the Department of Neurology at MedStar Georgetown University Hospital, Washington, DC, told Medscape Medical News after his presentation at the AAN meeting.
The study included 61 adult patients with BEB and showed that those who received single injections of a higher dose of incobotulinumtoxinA (50 U) had significantly greater improvement on symptom severity scores on the Jankovic Rating Scale than their counterparts who received matching placebo.
In addition, the improvements were sustained after a single dose of the study drug at less than 70 U during a 6- to 20-week open-label extension period. Most adverse events reported were mild to moderate in severity.
The drug was recently approved by the FDA for the treatment of sialorrhea (excessive drooling). It was also approved in 2015 for upper limb spasticity and in 2010 for cervical dystonia.
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Cite this: FDA OKs IncobotulinumtoxinA (Xeomin) First-Line in Blepharospasm - Medscape - May 13, 2019.