FDA Approves Broadened Indication for XEOMIN® (IncobotulinumtoxinA) as First-Line Treatment for Blepharospasm (Involuntary Blinking) in Adult Patients

RALEIGH, N.C.--(BUSINESS WIRE)--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(®) (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:

-- Talk to your health care provider or pharmacist

-- Visit www.xeomin.com to obtain the FDA-approved product labeling

-- 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 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.

It is not known if XEOMIN is safe and effective in children under 18 years of age.

Warnings

XEOMIN may cause serious side effects that can be life threatening. Call your doctor or get medical help right away if you have any of these problems anytime (hours to weeks) after treatment with XEOMIN:

-- Problems with swallowing, speaking, or breathing can happen within hours to weeks after an injection of XEOMIN if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.

- People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.

- Swallowing problems may last for several months, and during that time you may need a feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into your lungs. People who already have swallowing or breathing problems before receiving XEOMIN have the highest risk of getting these problems.

-- Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away from the injection site and cause symptoms of a serious condition called botulism. The symptoms of botulism include: loss of strength and muscle weakness all over the body, double vision, blurred vision and drooping eyelids, hoarseness or change or loss of voice, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.

Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN( )(see the end of this Guide for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYBLOC(®)), onabotulinumtoxinA (BOTOX(®), BOTOX(® )COSMETIC), or abobotulinumtoxinA (DYSPORT(®)) or have a skin infection at the planned injection site.

Before receiving XEOMIN, tell your doctor about all of your medical conditions, including if you:

-- have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome)

-- have had any side effect from any other botulinum toxin in the past

-- have a breathing problem such as asthma or emphysema

-- have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)

-- 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 XEOMIN can harm your unborn baby.

-- are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the- counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.

Using XEOMIN with certain other medicines may cause serious side effects Do not start any new medicines until you have told your doctor that you have received XEOMIN in the past.

Especially tell your doctor if you:

-- have received any other botulinum toxin product in the last four months

-- have received injections of botulinum toxin such as rimabotulinumtoxinB (MYOBLOC(®)), onabotulinumtoxinA (BOTOX(®), BOTOX(®) COSMETIC) and abobotulinumtoxinA (DYSPORT(®)) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.

-- 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 you to show your doctor and pharmacist each time you get a new medicine.

Possible Side Effects

XEOMIN can cause serious side effects including:

See “Warnings.”

-- Injury to the cornea (the clear front surface of the eye) in people treated for blepharospasm. People who receive XEOMIN to treat spasm of the eyelid may have reduced blinking that can cause a sore on their cornea or other problems of the cornea. Call your healthcare provider or get medical care right away if you have eye pain or irritation after treatment with XEOMIN.

-- XEOMIN may cause other serious side effects including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, trouble breathing, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or trouble breathing, or if you get dizzy or faint.

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 report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of XEOMIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.

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.

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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.