FDA Approves Broadened Indication for XEOMIN® (IncobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients
- Category: Proteins and Peptides
- Published on Monday, 13 May 2019 16:23
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RALEIGH, NC, USA I May 13, 2019 I Merz Americas announced today that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for XEOMIN® (incobotulinumtoxinA), broadening its indication to be a first-line treatment of blepharospasm (involuntary blinking) in adult patients.
“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 U.S.,”1 said Kevin O’Brien, Vice President and U.S. Head of Neurosciences, Merz. “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.”
Blepharospasm causes muscles around the eyes to contract involuntarily. Patients suffering from blepharospasm can experience symptoms including excessive blinking, light sensitivity, dry eyes, eye irritation and watering eyes, and symptoms may worsen over time.1,2
The approval is based on a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial in a total of 61 treatment-naïve patients who had a diagnosis of blepharospasm with a baseline Jankovic Rating Scale (JRS) Severity subscore ≥2. JRS is the most commonly used clinical scale to measure severity and frequency of blepharospasm. Patients were defined as treatment-naïve if at least 12 months had passed since their last toxin treatment.
The primary efficacy endpoint was the change from baseline in JRS Severity subscore determined at week 6 after the XEOMIN injection. The 50 unit treatment group demonstrated statistically significant improvement compared to placebo, with a difference of -1.2 (p=0.0004). The safety findings were similar to previous studies and in line with the known safety profile of XEOMIN.
XEOMIN was first approved by the FDA in 2010 for the treatment of blepharospasm (previously treated with onabotulinumtoxinA) and cervical dystonia in adult patients and later in 2015 for upper limb spasticity in adult patients. Most recently, XEOMIN was approved by the FDA in July 2018 to treat chronic sialorrhea (excessive drooling) in adult patients.
Merz in the Americas
Merz has a direct presence in six countries in the Americas, as well as a network of selected professional distribution partners in South and Central America and the Caribbean. Merz in the Americas is headquartered in Raleigh, North Carolina, and has facilities in Mesa, Arizona, Franksville, Wisconsin as well as affiliate offices in Toronto, Canada, Mexico City, Bogotá, Colombia, São Paolo, Brazil and Buenos Aires, Argentina.
|XEOMIN is a prescription medicine used in adults:|
|-- that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea).|
|-- that is injected into muscles and used to:|
|- treat increased muscle stiffness in the arm because of upper limb spasticity.|
|- treat the abnormal head position and neck pain with cervical dystonia (CD).|
|- treat abnormal spasm of the eyelids (blepharospasm) in adults.|
|1.||“Benign Essential Blepharospasm.” National Institutes of Health, USA.gov, 28 Aug. 2018, ghr.nlm.nih.gov/condition/benign-essential-blepharospasm#statistics. Last accessed May, 10 2019.|
|2.||Tsui JKC. Blepharospasm and hemifacial spasm. In: Brin MF, Comella C, Jankovic J, eds. Dystonia: Etiology, Clinical Features, and Treatment. Philadelphia, PA: Lippincott Williams & Wilkins; 2004:151-157.|