Celltrion's EU Clinical Trial Nod for Crohn's Disease Drug Lapses
Celltrion's (KRX:068270) said approval for Part 1 of its European Phase 3 clinical trial application for Remsima (CT-P13 SC) in pediatric patients with Crohn's Disease has lapsed, according to a Friday filing with the Korea Exchange.The approval lapsed on June 18 after the South Korean biopharmaceutical company opted not to submit Part 2 of the application, citing changes to its clinical development strategy.Under the European Union Clinical Trials Regulation, approval for Part 1 automatically lapses if Part 2 is not filed within two years.Celltrion said plans and timelines for the study will be determined following consultations with regulators on the trial design.Shares of Celltrion fell over 2% in recent trade.