First subcutaneous formulation of infliximab submitted to FDA

US Food and Drug Administration

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.”

Related Articles

Join FREE today and become a member
of Drug Discovery World

Membership includes:

  • Full access to the website including free and gated premium content in news, articles, business, regulatory, cancer research, intelligence and more.
  • Unlimited App access: current and archived digital issues of DDW magazine with search functionality, special in App only content and links to the latest industry news and information.
  • Weekly e-newsletter, a round-up of the most interesting and pertinent industry news and developments.
  • Whitepapers, eBooks and information from trusted third parties.
Join For Free