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Ipsen (IPN.PA) Announces FDA Approval Of Dysport (Abobotulinumtoxina) For The Treatment Of Lower Limb Spasticity In Adults



6/16/2017 10:57:30 AM

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Spasticity may affect adults who suffer from stroke, traumatic brain injury, spinal cord injury, multiple sclerosis, and cerebral palsy

PARIS--(BUSINESS WIRE)--Regulatory News:

Ipsen (Euronext: IPN; ADR: IPSEY) (Ipsen) today announced that the U.S. Food and Drug Administration (FDA) has expanded the approved use of Dysport® (abobotulinumtoxinA) for injection for the treatment of spasticity in adults, based on its supplemental Biologics License Application (sBLA) in lower limb spasticity. In July 2015, Dysport® was approved for the treatment of upper limb spasticity in adults. In July 2016, Dysport® was approved to treat pediatric patients with lower limb spasticity aged two and older, making it the first and only botulinum toxin that the FDA approved for this indication.

In a Phase III, multi-center, prospective, double-blind, randomized placebo-controlled study, adult patients treated with Dysport® following a stroke or traumatic brain injury showed improvement in muscle tone at the ankle joint, measured by the mean change from baseline on the Modified Ashworth Scale (MAS) at Week 4. The duration of response for the majority of patients within the study was between 12-16 weeks. In this study, some patients experienced a longer duration of response (approximately 20 weeks).

The degree and pattern of muscle spasticity at the time of re-injection may necessitate alterations in the dose of Dysport® and muscles to be injected. Repeat Dysport® treatment should be administered when the effect of a previous injection has diminished, but no sooner than 12 weeks after the previous injection.

Lower limb spasticity impacts a person’s movement. In adults, approximately one in three stroke patients, one in three patients with spinal cord injury, one in six patients with traumatic brain injury, and two in three patients with Multiple Sclerosis (MS) will develop lower limb spasticity.1,2 Adult patients with Cerebral Palsy (CP) also commonly experience spasticity in their lower limbs.1

“Adult patients who have developed spasticity as a result of a stroke, Multiple Sclerosis, Cerebral Palsy, spinal cord injury, or traumatic brain injury now have another option when seeking treatment that helps reduce the effects of the increased muscle tone in their lower extremities,” said Alexandre Lebeaut, MD, Executive Vice-President, R&D, Chief Scientific Officer, Ipsen.

Dysport® and all botulinum toxin products have a Boxed Warning which states that the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to those of botulism. Those symptoms include swallowing and breathing difficulties that can be life-threatening. Dysport® is contraindicated in patients with known hypersensitivity to any botulinum toxin preparation or to any of the components; or in the presence of infection at the proposed injection site(s); or in patients known to be allergic to cow’s milk protein. The potency Units of Dysport® are specific to the preparation and assay method utilized. They are not interchangeable with other preparations of botulinum toxin products. Please see below for additional Important Safety Information.

“Dysport® is currently the only botulinum toxin approved by the FDA for the treatment of spasticity in adults in upper and lower limbs and also for the treatment of lower limb spasticity in children ages two and older,” said Cynthia Schwalm, Executive Vice-President and President, North America Commercial Operations, Ipsen. “We are proud that Dysport® is now available to support an additional population of patients— including those adults managing their spasticity associated with stroke, brain injury, spinal cord injury, Multiple Sclerosis, or Cerebral Palsy—and that Ipsen is able to provide comprehensive support offerings, including the IPSEN CARES® patient assistance program and the C.L.I.M.B.® injector training platform for healthcare providers.”


Read at BioSpace.com


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