FDA Approves Broadened Indication for XEOMIN® (IncobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients
Patients were defined as treatment-nave if at least 12 months had passed since their last toxin treatment.
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(®) (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION |
Read the Medication Guide before you start receiving XEOMIN(®) |
-- Talk to your health care provider or pharmacist |
-- Visit www.xeomin.com |
-- Call 1-844-4MYMERZ |
Uses |
XEOMIN is a prescription medicine used in adults: |
-- that is injected into glands that make saliva and is used to
|
-- that is injected into muscles and used to: |
- treat increased muscle stiffness in the arm because of upper |
- treat the abnormal head position and neck pain with cervical |
- treat abnormal spasm of the eyelids (blepharospasm) in adults. |
It is not known if XEOMIN is safe and effective in children under |
Warnings |
XEOMIN may cause serious side effects that can be life |
-- Problems with swallowing, speaking, or breathing can happen |
- People with certain breathing problems may need to use muscles |
- Swallowing problems may last for several months, and during that |
-- Spread of toxin effects. In some cases, the effect of |
These symptoms can happen hours to weeks after you receive an |
Do not take XEOMIN if you: are allergic to XEOMIN or any of |
Before receiving XEOMIN, tell your doctor about all of your |
-- have a disease that affects your muscles and nerves (such as |
-- have had any side effect from any other botulinum toxin in the |
-- have a breathing problem such as asthma or emphysema |
-- have a history of swallowing problems or inhaling food or fluid |
-- have bleeding problems |
-- have drooping eyelids |
-- have plans to have surgery |
-- have had surgery on your face |
-- are pregnant or plan to become pregnant. It is not known if |
-- are breastfeeding or plan to breastfeed. It is not known if |
Tell your doctor about all of the medicines you take, |
Using XEOMIN with certain other medicines may cause serious side |
Especially tell your doctor if you: |
-- have received any other botulinum toxin product in the last |
-- have received injections of botulinum toxin such as |
-- have recently received an antibiotic by injection |
-- take muscle relaxants |
-- take an allergy or cold medicine |
-- take a sleep medicine |
Ask your doctor if you are not sure if your medicine is one that is listed above. |
Know the medicines you take. Keep a list of your medicines with |
Possible Side Effects |
XEOMIN can cause serious side effects including: |
See “Warnings.” |
-- Injury to the cornea (the clear front surface of the eye) in |
-- XEOMIN may cause other serious side effects including allergic |
The most common side effects of XEOMIN in people with chronic sialorrhea include: |
-- needing to have a tooth pulled (extracted) |
-- dry mouth |
-- diarrhea |
-- high blood pressure |
The most common side effects of XEOMIN in people with upper limb spasticity include: |
-- seizure |
-- nasal congestion, sore throat and runny nose |
-- dry mouth |
-- upper respiratory infection |
The most common side effects of XEOMIN in people with cervical dystonia include: |
-- difficulty swallowing |
-- neck pain |
-- muscle weakness |
-- pain at the injection site |
-- muscle and bone pain |
The most common side effects of XEOMIN in people with blepharospasm include: |
-- drooping of the eyelid |
-- dry eye |
-- vision problems |
-- dry mouth |
These are not all the possible side effects of XEOMIN. |
Call your doctor for medical advice about side effects. You may |
General information about the safe and effective use of XEOMIN |
Medicines are sometimes prescribed for purposes other than those |
Active Ingredient: botulinum toxin type A |
Inactive Ingredients: human albumin and sucrose |
Copyright © 2019 Merz North America, Inc. All rights reserved. MERZ, the
MERZ logo, and XEOMIN are registered trademarks of Merz Pharma GmbH &
Co. KGaA. Botox, Dysport and Myobloc are registered trademarks of their
respective owners.
For more information, please see XEOMIN full Prescribing Information and
Medication Guide at www.xeomin.com.
______________________ |
|
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. |
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