Cangene Corporation (Cangene) has announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold previously placed on clinical trials evaluating the safety and efficacy of IB1001, a recombinant Factor IX (rFIX) product being developed for the treatment and prevention of bleeding episodes with hemophilia B.
"IB1001 continues to provide an opportunity to address a significant global need for patients with hemophilia B, and we are pleased to be moving forward with our phase 3 studies," said John A. Sedor, President and Chief Executive Officer of Cangene.
Sedor continued, "Our manufacturing, analytical and clinical expertise has facilitated clinical hold removal and our regulatory interactions continue to shape the pathway to IB1001 licensure. We acquired IB1001 because we are confident in IB1001 and our ability to achieve its licensure, which will benefit hemophilia B patients and build value for our shareholders."
In a letter to the Company, the FDA acknowledged that Cangene had addressed all of the Agency's clinical hold issues and that the clinical hold had been lifted, effective immediately.
Cangene will now re-initiate ongoing studies and begin new studies in adult and pediatric patients, which will be used to submit updated licensure applications in the U.S. and Europe.
Specific clinical data requirements to support licensure may vary by jurisdiction and discussions are ongoing with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA).