HEADLINE:
Intercept Pharma Canada receives Health Canada approval for Ocaliva (obeticholic acid) for the treatment of patients with Primary Biliary Cholangitis
BYLINE:
Ocaliva represents first new treatment option for Primary Biliary Cholangitis in 20 years
LEAD PARAGRAPH:
Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced that Health Canada has granted a Notice of Compliance (NOC) approving Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (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. …show more content…
It is the leading cause of liver transplantation in females.
• Ocaliva is a first-in-class farnesoid X receptor (FXR) agonist that will offer an important new treatment option for the substantial number of Canadian patients who have an inadequate response to UDCA and are at increased risk of liver failure, need for liver transplantation, or death
• Ocaliva is currently moving through the independent drug approval process in Canada, with a coverage recommendation expected in June.