Ipsen announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Dysport® (botulinum toxin of type A) Biologics License Application (BLA) for the treatment of patients with cervical dystonia has been extended to no later than 28 December 2008.
This regulatory decision will not impact the anticipated company launch plan timing. The FDA has not requested additional safety or clinical studies for review. In accordance with first-cycle review of new therapies, the FDA requested a Risk Communication Plan in order to ensure safe use of the product in treating patients. The Agency has therefore extended the PDUFA action date to no later than December 28, 2008, in order to finalize the review of those items.
“We are assembling the requested information from the dossier, in close coordination with the FDA,” said Stéphane Thiroloix, Executive Vice-President, Corporate Development of the Ipsen Group. “We strongly believe that appropriate recommendations through vehicles like patient medication guide and appropriate direct communications to attending physicians are the way forward to enhance and further define information already available in the package inserts. In meeting the Agency’s information need, Ipsen also addresses a patient-care imperative.”
Dysport® has been granted orphan product status by the FDA as a treatment for cervical dystonia, an orphan disease in the United States. The BLA submission relies on data from two pivotal Phase III studies performed in the United States and abroad totalling 252 patients followed-up for up to 12 treatment cycles, in addition to substantial patient exposure in other clinical studies in cervical dystonia. The timeline for the US commercialisation of Dysport® is unchanged from original plans, and the US neurology team is preparing diligently for the launch.
Used in patient care in the United Kingdom since 1991, Dysport® has marketing authorizations in more than 70 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 US for eight indications including cervical dystonia (involuntary distorsions of the neck).