FDA approves Dysport for therapeutic, aesthetic uses

April 30, 2009

Medicis (NYSE:MRX) and Ipsen (Euronext:IPN) 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, according to GlobeNewswire.com.

International report - Medicis (NYSE:MRX) and Ipsen (Euronext:IPN) 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, according to GlobeNewswire.com.

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.