Source: www.globenewswire.com
 
Medicis and Ipsen today announced the U.S. Food and Drug Administration's (FDA) approval of the Biologics License Application (BLA) for DYSPORT™ (abobotulinumtoxinA), an acetylcholine release inhibitor and a neuromuscular blocking agent. The approval includes two separate indications, the treatment of cervical dystonia in adults to reduce the severity of abnormal head position and neck pain, and the temporary improvement in the appearance of moderate to severe glabellar lines in adults younger than 65 years of age. Reloxin®, which was the proposed U.S. name for Ipsen's botulinum toxin product for aesthetic use, will be marketed under the name of DYSPORT™ Ipsen will market DYSPORT™ in the United States for the therapeutic indication (cervical dystonia), while Medicis will market DYSPORT™ in the U.S. for the aesthetic indication (glabellar lines). Additionally, DYSPORT™ is differentiated from other marketed botulinum toxin products with the unique established name abobotulinumtoxinA.

The REMS for DYSPORT™ is designed to help prevent medication errors related to the lack of interchangeability of DYSPORT™ with other marketed botulinum toxin products, and ensure that the potential benefits of treatment with DYSPORT™ outweigh any potential risk of the spread of toxin effect beyond the injection site. The labeling for DYSPORT™ also contains a boxed warning about the potential distant spread of all botulinum toxin products, including DYSPORT™.
Ipsen anticipates launching DYSPORT™ for the treatment of cervical dystonia in the U.S. during the second half of 2009. Furthermore, in terms of post-marketing commitments for DYSPORT(TM), Ipsen is notably committed to perform clinical studies in children and adults with spasticity.

About Cervical Dystonia
Cervical dystonia is an orphan condition in the U.S. affecting approximately 125,000 people. It is a chronic and painful condition characterized by neck muscles contracting involuntarily, which causes abnormal movements and awkward posture of the head and neck. Symptoms usually begin in people age 40 years or older, and women are more commonly affected by the condition than men.

About DYSPORT™ (abobotulinumtoxinA)
The active substance in DYSPORT™ is a botulinum neurotoxin type A complex, which acts at the level of the neuromuscular junction in the targeted muscle. DYSPORT™ is a neuromuscular blocking toxin which acts to block acetylcholine release at motor nerve ends and reduces muscular spasm.
Used in patient care in the United Kingdom since 1991, DYSPORT™ has marketing authorizations in 76 countries for therapeutic use and in 27 countries for aesthetic use. Patient exposure is estimated to be above two million single treatment cycles, representing more than 600,000 patients year of treatment.
DYSPORT™ was initially developed and subsequently approved in many markets around the world, outside the U.S., for the treatment of movement disorders such as cervical dystonia (spasmodic torticollis), blepharospasm (involuntary eye closure), hemifacial spasm and various forms of muscle spasticity, including post-stroke arm spasticity, spasticity of the lower limbs (calf) in adults and children with cerebral palsy. It was later developed for the treatment of a wide variety of neuromuscular disorders and aesthetic medicine.

"The FDA's approval for the DYSPORT™ is an important breakthrough for Ipsen" said Meir Jakobsohn, president of Medison pharma "there is no doubt that DYSPORT™ the leading product in Israel and Europe will also achieve a significant market segment in the USA"

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