Ipsen has announced that the US Food and Drug Administration (FDA) issued a Complete Response Letter for its Biologics License Application (BLA) for its Botulinum toxin Type A, Dysport.
The application, submitted by the Group in late 2007, seeks approval to market Dysport for the treatment of cervical dystonia. The Group is now actively preparing to launch the product, once approved by the FDA, and as soon as reimbursement coverage is adequate.
The FDA has not requested any new clinical studies evaluating the efficacy or safety of Dysport prior to approval. The Complete Response Letter requests additional information, including the finalization of the Risk Evaluation and Mitigation Strategy (REMS) and of the draft labelling, as well as a Safety Update Report. Based on the information identified in the FDA's end of review complete response letter, Ipsen expects to submit the information to FDA during the first quarter of 2009.
Furthermore, FDA has confirmed in its Establishment Inspection Report that the manufacturing process for Dysport in its Wrexham (Wales) facility is in compliance with CGMPs 1 . The FDA issued no Form 483 observation. The Wrexham site gathers the manufacturing, product formulation, packaging and testing activities for the entire production of botulinum toxin type A currently marketed in 73 countries under the brand name Dysport .
"We are confident that we can expeditiously respond to the questions set forth in the Complete Response Letter" said Stéphane Thiroloix , Ipsen's Executive Vice President - Corporate Development. "We anticipate answering to the FDA during the first quarter of 2009 and remain focused on bringing Dysport to market as originally planned."
Dysport has been approved as a treatment for cervical dystonia, an orphan disease in the United States.
Used in patient care in the United Kingdom since 1991, Dysport has marketing authorizations in 73 countries. Patient exposure is estimated to be above two million single treatment cycles representing more than 600,000 patients year of treatment. Dysport is approved outside the U.S. for eight indications including cervical dystonia (involuntary distorsions of the neck).
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. It was initially developed and subsequently approved in many markets around the world 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.