LG Chem has withdrawn phase 3 clinical trials in Europe for its new gout treatment drug "LC350189." LG Chem plans to revise and reapply for the clinical design of "Tigulixostat" after receiving a request for clinical modification from a European clinical approval agency.
LG Chem announced on the 10th that it will withdraw its plan for a phase 3 clinical trial in Europe for "Tigulixostat," a new drug for gout treatment.
LG Chem has designed the clinical design of "EURELIA 1 Study" based on consultations with the US FDA and guidelines from the European Medicines Agency (EMA). LG Chem applied for the same phase 3 clinical trial to FDA and EMA, and FDA approved the clinical plan in September.
The clinical trial has already been approved in the U.S. and phase 3 clinical trials are underway, LG Chem said. "We will discuss clinical design through EMA's academic advisory meeting and re-apply for the European clinical trial plan."
Alphabiz Reporter Kim Jisun(stockmk2020@alphabiz.co.kr)
