CAMBRIDGE, Mass.–(BUSINESS WIRE) July 09, 2020 –Ipsen Biopharmaceuticals, an affiliate of Ipsen (Euronext: IPN; ADR: IPSEY), announced today that the United States Food and Drug Administration (FDA) has approved the expanded use of Dysport (abobotulinumtoxinA) in pediatric patients. When Dysport was first FDA-approved in 2016 for pediatric lower limb spasticity, Ipsen was granted Orphan Drug exclusivity for pediatric patients whose lower limb spasticity was caused by cerebral palsy (CP).¹ Similarly, in 2019, Dysport received FDA approval for the treatment of upper limb spasticity in children two years of age and older, excluding upper limb spasticity caused by CP, due to Orphan Drug exclusivity granted to another manufacturer.¹ Ipsen has worked with the FDA and this manufacturer to selectively waive their respective exclusivities to better support patient care. As a result, Dysport is now FDA-approved to treat both upper and lower limb spasticity in pediatric patients two years of age and older, including spasticity caused by cerebral palsy.¹

“The proactive step to resolve the uncertainty created by the previous CP carveout enables us as physicians to prescribe consistent therapy for pediatric
“The proactive step to resolve the uncertainty created by the previous CP carveout enables us as physicians to prescribe consistent therapy for pediatric patients experiencing both upper and lower limb spasticity,” said Sarah Helen (Sally) Evans, MD, Division Chief of Rehabilitation Medicine in the Department of Pediatrics at the Children’s Hospital of Philadelphia. “This update ensures patient care, and treating the child as a whole person, can be the focus for physicians and their caregivers when making treatment decisions for both upper and lower limb spasticity.”

“We’re proud to have proactively worked with the FDA and another manufacturer to help physicians treat their patients in the manner they deem best for their patients’ care,” said Kimberly Baldwin, Vice President, Franchise Head, Neuroscience Business Unit, Ipsen. “This effort illustrates our continued commitment to patients, helping to ensure children living with cerebral palsy can access the spasticity treatment that’s most appropriate for them.”

About Pediatric Spasticity

Spasticity is a condition in which there is an abnormal increase in muscle tone or stiffness in one or more muscles, which might interfere with movement.²

Spasticity affects the muscles and joints of the extremities, and particularly impacts growing children.3 Spasticity is usually caused by damage to nerve pathways in the brain or spinal cord that control muscle movement, and may occur in association with CP, spinal cord injury, multiple sclerosis, stroke, and brain or head trauma.^2,3

Symptoms of spasticity may include increased muscle tone, rapid muscle contractions, exaggerated deep tendon reflexes, and/or muscle spasms.^2,3 The degree of spasticity can vary from mild muscle stiffness to severe, painful, and uncontrollable muscle spasms.²

Spasticity in children is a condition that causes muscle spasms and increased muscle stiffness in either the upper and/or lower limbs including the elbow, wrist, finger and calf muscles.¹ When muscle stiffness in the calf is intensified, it prohibits the ankle from flexing as needed and causes the foot to be pointed down and in.^1,4

About Dysport (abobotulinumtoxinA) for Injection

Dysport is an injectable form of botulinum toxin type A (BoNT-A), which is isolated and purified from Clostridium bacteria producing BoNT-A.¹ It is supplied as a lyophilized powder.¹ Dysport has approved indications in the United States for the treatment of adults with cervical dystonia (CD) and for the treatment of spasticity in adult patients.¹ Dysport is also the first FDA-approved botulinum toxin for the treatment of both upper and lower limb spasticity in children two years of age or older.¹

INDICATIONS

Dysport® (abobotulinumtoxinA) for injection is indicated for the treatment of:

• Spasticity in patients 2 years of age and older
• Cervical dystonia in adults

About Ipsen in North America

Ipsen (Euronext: IPN; ADR: IPSEY) is a global biopharmaceutical company focused on innovation and specialty care. The company develops and commercializes innovative medicines in three key therapeutic areas –Oncology, Neuroscience and Rare Diseases. At Ipsen, we focus our resources, investments and energy on discovering, developing and commercializing new therapeutic options to provide hope for patients whose lives are challenged by difficult-to-treat diseases. Ipsen’s North American operations are located in Cambridge, Massachusetts, one of the company’s three global hubs. Based in the heart of Kendall Square, our fully integrated biopharmaceutical business includes Commercial, Research & Development, Manufacturing, and Global External Innovation and Partnering. Combined with our Canadian headquarters in Mississauga, Ontario, and other locations, Ipsen employs approximately 600 people in North America. For more information please visit www.ipsenus.com or www.ipsen.ca. Connect with us on Twitter and LinkedIn.

Forward-Looking Statement
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1. 1 Dysport (abobotulinumtoxinA) [Prescribing Information]. Cambridge, MA: Ipsen Biopharmaceuticals, Inc; July 2020.
   2 National Institute of Neurological Disorders and Stroke. Spasticity Information Page. https://www.ninds.nih.gov/Disorders/All-Disorders/Spasticity-Information-Page. Accessed May 12, 2020.
   3 American Association of Neurological Surgeons. Spasticity page. http://www.aans.org/Patients/Neurosurgical-Conditions-and-Treatments/Spasticity. Accessed May 12, 2020.
   4 Delgado MR, Tilton A, Russman B, et al. (2016). AbobotulinumtoxinA for Equinus Foot Deformity in Cerebral Palsy: A Randomized Controlled Trial. Pediatrics. 2016;137(2);1-9.

Source: Ipsen Biopharmaceuticals

Posted: July 2020

Related Articles:

• Ipsen Announces FDA approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Adults – June 16, 2017
• Ipsen Biopharmaceuticals, Inc. Announces FDA Approval of Dysport (abobotulinumtoxinA) for the Treatment of Lower Limb Spasticity in Pediatric Patients Aged Two and Older – August 1, 2016
• Ipsen Announces FDA Approval of Dysport (abobotulinumtoxinA) for Upper Limb Spasticity – July 17, 2015
• FDA Approves Dysport (abobotulinumtoxinA) for Cervical Dystonia and Glabellar Lines – April 30, 2009
• FDA Issues Complete Response Letter to Ipsen for Dysport Biologics License Application – December 29, 2008
• Ipsen and Medicis Announce Acceptance of Reloxin BLA in Aesthetics by FDA – May 19, 2008
• Ipsen and Medicis Announce Submission of Reloxin BLA in Aesthetics to the FDA – March 17, 2008
• Ipsen: FDA Accepts for Filing a Biologics License Application (BLA)
  for Dysport in Cervical Dystonia – January 31, 2008
• Ipsen and Medicis Announce Submission of Reloxin in Aesthetics to the FDA – December 6, 2007
• Ipsen Submits a Biologics License Application in Cervical Dystonia
  to the FDA for Dysport – December 6, 2007

Dysport (abobotulinumtoxinA) FDA Approval History