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The decision follows a request from the FDA. The FDA has also placed a clinical hold on all of Intercept’s clinical trials involving obeticholic acid.
PBC is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent in women older than 40 years of age. PBC causes a buildup of bile acid in the liver, resulting in inflammation and fibrosis, which — if not treated — can lead to cirrhosis, a liver transplant, or death.
Ocaliva, a farnesoid X receptor agonist, received accelerated FDA approval in 2016 for the treatment of PBC in adults with an inadequate response to or intolerance of ursodeoxycholic acid.
Yet, in September 2024, staff reviewers at the FDA said a confirmatory trial did not show that the drug was effective for PBC.
Ocaliva has also been linked to an increased risk of serious liver injury in patients with PBC with and without cirrhosis.
The company has advised patients currently taking Ocaliva for PBC to consult their healthcare provider before making any changes.
Intercept will provide additional information to support healthcare professionals and patients as it works with the FDA on the transition process.
Healthcare professionals who have questions about this development can contact Intercept Medical Information at medinfo@interceptpharma.com or call 1-844-782-4278.
A version of this article appeared on Medscape.com.
The decision follows a request from the FDA. The FDA has also placed a clinical hold on all of Intercept’s clinical trials involving obeticholic acid.
PBC is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent in women older than 40 years of age. PBC causes a buildup of bile acid in the liver, resulting in inflammation and fibrosis, which — if not treated — can lead to cirrhosis, a liver transplant, or death.
Ocaliva, a farnesoid X receptor agonist, received accelerated FDA approval in 2016 for the treatment of PBC in adults with an inadequate response to or intolerance of ursodeoxycholic acid.
Yet, in September 2024, staff reviewers at the FDA said a confirmatory trial did not show that the drug was effective for PBC.
Ocaliva has also been linked to an increased risk of serious liver injury in patients with PBC with and without cirrhosis.
The company has advised patients currently taking Ocaliva for PBC to consult their healthcare provider before making any changes.
Intercept will provide additional information to support healthcare professionals and patients as it works with the FDA on the transition process.
Healthcare professionals who have questions about this development can contact Intercept Medical Information at medinfo@interceptpharma.com or call 1-844-782-4278.
A version of this article appeared on Medscape.com.
The decision follows a request from the FDA. The FDA has also placed a clinical hold on all of Intercept’s clinical trials involving obeticholic acid.
PBC is a rare, progressive, and chronic autoimmune disease that affects the bile ducts in the liver and is most prevalent in women older than 40 years of age. PBC causes a buildup of bile acid in the liver, resulting in inflammation and fibrosis, which — if not treated — can lead to cirrhosis, a liver transplant, or death.
Ocaliva, a farnesoid X receptor agonist, received accelerated FDA approval in 2016 for the treatment of PBC in adults with an inadequate response to or intolerance of ursodeoxycholic acid.
Yet, in September 2024, staff reviewers at the FDA said a confirmatory trial did not show that the drug was effective for PBC.
Ocaliva has also been linked to an increased risk of serious liver injury in patients with PBC with and without cirrhosis.
The company has advised patients currently taking Ocaliva for PBC to consult their healthcare provider before making any changes.
Intercept will provide additional information to support healthcare professionals and patients as it works with the FDA on the transition process.
Healthcare professionals who have questions about this development can contact Intercept Medical Information at medinfo@interceptpharma.com or call 1-844-782-4278.
A version of this article appeared on Medscape.com.