Medicis and Ipsen win FDA approval for Dysport

US-based Medicis and French pharmaceutical company Ipsen have reported that the FDA has approved the biologics license application for Dysport, 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 US name for Ipsen’s botulinum toxin product for aesthetic use, will be marketed under the name of Dysport. Ipsen will market Dysport in the US for the therapeutic indication (cervical dystonia), while Medicis will market Dysport in the US for the aesthetic indication (glabellar lines). Additionally, Dysport is differentiated from other marketed botulinum toxin products with the established name abobotulinumtoxinA, said Ipsen.

Medicis anticipates shipping Dysport for aesthetic use in the US during the next 30 to 60 days. During that time, Medicis will complete the training of its aesthetic sales force. McKesson will serve as the US distributor of Dysport for aesthetic use. Ipsen will manufacture and provide the product to Medicis for the term of the agreement, which extends until December 2036.

Jean-Luc Belingard, chairman and CEO of Ipsen, said: The approval of our Dysport biologics license application by the FDA for both therapeutic and aesthetic indications is the fruit of hard work and efficient organization of both the Ipsen and Medicis teams. Dysport represents an important new treatment option for patients suffering from cervical dystonia, and we hope to capitalize on our successful therapeutic focus worldwide to build as strong a position in the US.