After twelve long months, Cangene Corporation has finally announced that the clinical hold placed on its hemophilia compound IB1001 by the US Food and Drug Administration (FDA) has been lifted. The hold had effectively stalled two clinical studies into the safety and efficacy of the IB1001, a recombinant Factor IX product for the treatment and prevention of bleeding episodes in patients with hemophilia B, a rare, inherited condition that leaves a person’s blood unable to clot.
“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 CEO of Cangene. “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 an official letter sent to Cangene, the FDA acknowledged that the company had addressed all of the factors that inspired the hold and that the clinical hold would be lifted immediately.
Cangene will restart the halted trials in addition to beginning more studies in adult and pediatric patients. The results of these trials will be used to submit updated licensure applications in the US and Europe.
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