FDA Accepts for Filing Supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumt

 Merz North America announced today that the U.S. Food and Drug Administration (FDA) has accepted for filing a supplemental Biologics License Application (sBLA) for Xeomin® (incobotulinumtoxinA) for the treatment of chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients. The sBLA is based on a Phase III study, which met both of its co-primary endpoints for subjects administered 100 U incobotulinumtoxinA by achieving statistically significant change in unstimulated salivary flow rate (uSFR), and in the subjects’ Global Impression of Change Scale (GICS). The FDA has set a Prescription Drug User Fee Act (PDUFA) action date in Q4 2018, and if approved, has the potential to make Xeomin the first neurotoxin with this indication in the U.S.

"Sialorrhea is a common problem among people living with neurological disorders, causing added physical and psychosocial challenges for patients as well as caregivers," said David Dobrowski, Vice President of Research and Development, Merz North America. "We believe Xeomin can help manage excessive drooling, and we look forward to continuing to work closely with the FDA as they review our application."

The sBLA is based on a Phase III, randomized, double-blind, placebo-controlled, multicenter 184 subject trial. Both co-primary endpoints were successfully achieved. A statistically significant improvement was observed in change in uSFR at week four as compared to baseline pre-injection, for subjects administered 100 U incobotulinumtoxinA vs. placebo, and in the subjects’ GICS at week four for subjects administered 100 U incobotulinumtoxinA vs. placebo (p=0.004 and p=0.002, respectively). GICS is a commonly used rating system for treatments of neurological disorders by clinicians. Overall frequency of adverse events was similar between placebo and treatment groups with no new or unexpected adverse events reported. Subjects enrolled in the study received placebo (n=36), incobotulinumtoxinA 75 U (n=74), or incobotulinumtoxinA 100 U (n=74).

Results of the study were presented at last year’s International Congress of Parkinson’s Disease and Movement Disorders (MDS), American Academy of Physical Medicine and Rehabilitation (AAPM&R) and American Congress of Rehabilitation Medicine (ACRM) annual meetings.

About Merz Neurosciences

Merz Neurosciences is a division of Merz North America and is deeply committed to offering novel therapeutic options that address the largely unmet medical needs that exist within the area of neuroscience. Merz Neurosciences is an important contributor to the U.S. neurosciences space and offers a portfolio that includes the neurotoxin Xeomin® (incobotulinumtoxinA), the anticholinergic Cuvposa® (glycopyrrolate) Oral Solution and the Prolaryn® injectable implant family of products. 

About Merz North America, Inc.

Merz North America, Inc. is a specialty healthcare company dedicated to the development and marketing of innovative quality products for physicians and patients across the United States and Canada. Merz products are distributed through two divisions, Aesthetics and Neurosciences, and are developed with the goal of improving patients’ health and quality of life by delivering therapies that bring about real progress. Privately-held, Merz North America is headquartered in Raleigh, North Carolina. 

About XEOMIN® (incobotulinumtoxinA)

Xeomin® (incobotulinumtoxinA) is a prescription medicine that is injected into muscles and used to treat increased muscle stiffness in the arm of adults with upper limb spasticity, the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults, and to treat abnormal spasm of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (Botox®).

XEOMIN® 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.

Uses

XEOMIN® is a prescription medicine that is injected into muscles and used to treat:

• increased muscle stiffness in the arm of adults with upper limb spasticity
• abnormal head position and neck pain in adults with cervical dystonia (CD)
• abnormal spasm of the eyelids (blepharospasm) in adults who have had prior treatment with onabotulinumtoxinA (BOTOX®)

It is not known whether XEOMIN® is safe or effective in children.

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 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 (Myobloc®), onabotulinumtoxinA (Botox®, Botox® Cosmetic), or abobotulinumtoxinA (Dysport®) or have a skin infection at the planned injection site.

Ask a doctor before use 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 your medical conditions and all of the medicines you take, including: prescription and over-the-counter medicines, vitamins and herbal supplements. 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
• take a blood thinner medicine

Ask your doctor if you are not sure if your medicine is one that is listed above.

Possible Side Effects

XEOMIN® can cause serious side effects that can be life threatening. See "Warnings."

The most common side effects of XEOMIN® include:

• dry mouth
• discomfort or pain at the injection site
• tiredness
• headache
• neck pain
• muscle weakness
• eye problems, including double vision, blurred vision, drooping eyelids, swelling of your eyelids, and dry eyes. Reduced blinking can also occur. Tell your doctor or get medical help right away if you have eye pain or irritation following treatment.

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

Directions

• XEOMIN® is a shot (injection) that your doctor will give you.
• XEOMIN® is injected into your affected muscles.
• Your doctor may change your dose of XEOMIN® until you and your doctor find the best dose for you.

General information about the safe and effective use of XEOMIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use XEOMIN for a condition for which it was not prescribed. Do not give XEOMIN to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.

Active Ingredient: incobotulinumtoxinA
Inactive Ingredients: human albumin and sucrose

Copyright © 2018 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.

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