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FDA approves Medicis/Ipsen botulinum-toxin product for two indications

Article-FDA approves Medicis/Ipsen botulinum-toxin product for two indications

Scottsdale, Ariz. — Medicis, based here, and Paris-based Ipsen recently announced the Food and Drug Administration’s approval of the Biologics License Application (BLA) for DYSPORT™, an acetylcholine release inhibitor and neuromuscular blocking agent, reports news source Reuters.

The approval includes two indications, one for the treatment of cervical dystonia in adults and the other for temporary improvement in the appearance of moderate to severe glabellar lines in adults up to age 65. Reloxin®, 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, while Medicis will market DYSPORT™ domestically for the aesthetic indication. Also, Reuters reports, DYSPORT™ will be differentiated from other marketed botulinum toxin products by the name abobotulinumtoxinA.

Reuters quotes Medicis Chairman and C.E.O. Jonah Shacknai as saying, “Medicis and Ipsen have been diligent in efforts with the FDA to achieve this goal. We are excited to be entering the market for the most popular nonsurgical aesthetic procedure in the U.S. and anticipate being highly competitive.”

Jean-Luc Belingard, Ipsen’s chairman and c.e.o., is quoted as saying, “The approval of our DYSPORT™ BLA 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. We are proud to have closely collaborated with the FDA on the labeling and Risk Evaluation and Mitigation Strategy [REMS] for increased patient safety awareness in the use of DYSPORT™.”

The REMS is designed to help prevent medication errors related to the lack of interchangeability of DYSPORT™ with other botulinum toxin products, and ensure that the potential benefits of treatment with DYSPORT™ outweigh any risk of the of toxin effect spreading beyond the injection site. DYSPORT™ also contains a boxed warning about the potential distant spread of all botulinum toxin products, including DYSPORT™.

Three years ago, Ipsen granted Medicis the rights to develop, distribute and market Ipsen’s botulinum toxin product for aesthetic use by physicians in the U.S., Canada and Japan. In accordance with the agreement, Medicis will now pay Ipsen approximately $75 million as a result of the FDA approval. Medicis anticipates shipping DYSPORT™ for aesthetic use by summer. Ipsen will manufacture and provide the product to Medicis for the term of the agreement, which extends until December 2036.

 Ipsen anticipates launching DYSPORT™ for clinical indications later this year.

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