Healio

Patients with PBC who failed with obeticholic acid may still achieve ‘some benefit’

Please provide your email address to receive an email when new articles are posted on . Incomplete responders to obeticholic acid had significant increases from baseline in fibroblast growth factor 19 ...
MedPage Today

Will Fresh Look at Obeticholic Acid Data in NASH Sway FDA?

WASHINGTON -- A daily oral dose of obeticholic acid (Ocaliva) led to improvement in liver fibrosis without disease worsening for patients with non-alcoholic steatohepatitis (NASH), and with a good ...
MedPage Today

FDA Rejects Full Approval of Liver Disease Drug

The FDA declined to grant full approval to obeticholic acid (Ocaliva) for treating primary biliary cholangitis (PBC), Intercept Pharmaceuticals announced on Tuesday. The decision follows a September ...
Monthly Prescribing Reference

FDA Denies Full Approval of Obeticholic Acid for Primary Biliary Cholangitis

According to the CRL, the FDA is continuing to assess the safety data and is therefore not able to approve the sNDA in its current form. The Food and Drug Administration (FDA) has issued a Complete ...
Medscape

Non-Response to Obeticholic Acid May Predict Clinical Outcomes in Primary Biliary Cholangitis

Biochemical non-response to obeticholic acid as a second-line therapy predicted a heightened risk for clinical events in patients with primary biliary cholangitis (PBC). Although response rates to ...
Nasdaq

Intercept Pharma: REVERSE Phase 3 Study Of Obeticholic Acid Fails To Meet Primary Endpoint

(RTTNews) - Intercept Pharmaceuticals, Inc. (ICPT) announced that REVERSE, a phase 3 study evaluating the safety and efficacy of Obeticholic Acid in patients with compensated cirrhosis due to ...
Healio

Obeticholic acid flops in phase 3 trial for compensated NASH-related cirrhosis

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Obeticholic acid failed to demonstrate superiority to ...
Seeking Alpha

Intercept: Huge Potential Upsides With Binary Catalyst Unlocking

Due to what is seemingly a successful comeback, you can expect Intercept Pharmaceuticals to potentially deliver several-fold returns. Obeticholic acid's revenue for PBC alone is nearly enough to bank ...
Seeking Alpha

Intercept Announces FDA Acceptance of Supplemental New Drug Application for Ocaliva® (obeticholic acid) for the Treatment of PBC

sNDA intended to satisfy post-marketing requirements to confirm a clinical benefit in patients with PBC Precedent-setting submission includes data from post-marketing studies COBALT and Study 401 as ...
Monthly Prescribing Reference

Obeticholic Acid Under Review for Pre-Cirrhotic Liver Fibrosis Due to NASH

The NDA is supported by two 2 positive interim analyses from the phase 3 REGENERATE trial that included patients with biopsy-proven stage 2 or 3 liver fibrosis due to NASH. The Food and Drug ...
Nasdaq

Intercept Announces New PBC Data Analyses to be Presented at Digestive Disease Week® 2024 Conference

MORRISTOWN, N.J., May 09, 2024 (GLOBE NEWSWIRE) -- Intercept Pharmaceuticals, Inc., a biopharmaceutical company and wholly owned subsidiary of Alfasigma S.p.A. focused on the development and ...