Intercept Pharma (ICPT) Files Obeticholic Acid NDS with Health Canada

September 19, 2016 7:04 AM EDT

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Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT) announced the filing of a New Drug Submission to Health Canada, seeking Canadian marketing approval for obeticholic acid (OCA) for the treatment of primary biliary cholangitis, also referred to as primary biliary cirrhosis (PBC), when used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.

"Our submission to Health Canada not only reflects a significant milestone for Intercept, but more importantly for the estimated 8,000 Canadians living with PBC, many of whom remain at risk of liver failure and need for transplantation despite the current standard of care,” said Dr. Mark Pruzanski, President & CEO of Intercept Pharmaceuticals. “We are pleased with Health Canada’s decision to grant OCA priority review status, recognizing the high unmet medical need for new therapies in PBC and the potential of OCA to offer meaningful benefits in improving outcomes for patients impacted by the disease.”

PBC is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. It is primarily a disease of women, affecting approximately one in 1,000 women over the age of 40. If left untreated, survival of patients with PBC is significantly worse than that of the general population.

Canadian researchers have played a significant role in advancing the clinical research and management of PBC. With seven clinical trial sites across the country participating in the OCA PBC clinical development program, Canadian clinicians, patients and health institutions have made a meaningful contribution to the development of OCA.

“Both patients and doctors have been looking forward to new avenues of treatment for PBC patients at risk of disease progression. We have made great inroads in understanding what may cause PBC but this has not really impacted patient care - for a rare disease there are too many patients with PBC waiting for liver transplantation,” said Dr. Andrew Mason, Director of Research for the Division of Gastroenterology and Hepatology at the University of Alberta. “In clinical trials, OCA made a significant and clinically meaningful impact on lab tests used to monitor biliary disease, such as alkaline phosphatase and bilirubin. We are hopeful that OCA will be available soon for our patients with PBC.”

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