Celltrion submits application for subcutaneous infliximab in inflammatory bowel disease
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Celltrion has submitted a biologics license application to the FDA for the consideration of a subcutaneous formulation of infliximab in the treatment of inflammatory bowel disease, according to a press release.
“This BLA submission marks a significant milestone for Celltrion and we are working with the FDA to bring this innovative treatment to the U.S. market,” Hyoung Ki Kim, vice chairman and CEO of Celltrion Healthcare, said in the release. “We are committed to furthering the advancement of innovative treatments that provide improvements to clinical outcomes and drug pharmacology and reduce patients’ burden on their day-to-day lives.”
The submission is based on results from two phase 3 trials investigating the drug’s potential as a maintenance therapy for ulcerative colitis and Crohn’s disease. LIBERTY-UC and LIBERTY-CD were each randomized, placebo-controlled, double-blind phase 3 studies investigating the formulation, called CT-P13 SC, in which patients were randomized at 10 weeks and evaluated for primary endpoints at 54 weeks, according to the company.
In both trials, the test drug was significantly superior to placebo (oth P < .0001).
“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,” Jaeik Shim, chief operating officer of Celltrion USA, said in the release. “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.”
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