Celltrion USA has submitted a Biologics License Application (BLA) under the 351 (a) pathway of the Public Health Service Act for CT-P13 SC for the treatment of inflammatory bowel disease (IBD).
The submission is based on results from the Phase III pivotal data that evaluated the efficacy and safety of CT-P13 SC as maintenance therapy in patients with moderate to severe active ulcerative colitis (UC) and Crohn’s disease (CD).
Based on the results of the LIBERTY-UC and LIBERTY-CD studies, CT-P13 SC demonstrated superiority over placebo in maintenance therapy after induction therapy of intravenous formulation of infliximab in patients with UC and CD respectively, over a one-year treatment period.
“This BLA submission marks a significant milestone for Celltrion and we are working with the FDA to bring this innovative treatment to the US market,” said Hyoung Ki Kim, Vice Chairman & CEO, Celltrion Healthcare.
The company believes a subcutaneous formulation has the potential to enhance treatment options for the use of infliximab by providing high consistency in drug exposure and a convenient method of administration.
“We’re excited about the potential of CT-P13 SC as it allows patients to have more control of their treatment, providing much better independence and convenience,” added Jaeik Shim, Chief Operating Officer, Celltrion USA. “In addition, CT-P13 SC releases the burden of having to travel to treatment for IV infusions, reducing treatment-related travel costs for patients and caregivers.”