Drugs

Intercept Hit With 2nd Denial on NASH Drug

FDA has issued Intercept Pharmaceuticals a second complete response letter on its NDA resubmission for obeticholic acid (OCA) for treating pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH). The letter told Intercept that any NDA resubmission would require, at a minimum, successful completion of the long-term outcomes phase of the company’s REGENERATE study. The company says that based on the letter it has “decided to discontinue all NASH-related investment.”

In 2020, FDA issued the first complete response letter on the NDA and determined that the “predicted benefit of OCA based on a surrogate histopathologic endpoint remains uncertain and does not sufficiently outweigh the potential risks to support accelerated approval for the treatment of patients with liver fibrosis due to NASH,” according to the company.

Intercept said the January resubmission was supported by data from its OCA NASH clinical development program, including two positive, interim 18-month analyses from the pivotal Phase 3 REGENERATE study in patients with pre-cirrhotic liver fibrosis due to NASH. “In these analyses, OCA 25 mg consistently demonstrated double the response rate of placebo in a reduction in liver fibrosis stage without worsening of any of the three histologic components of NASH, an endpoint consistent with FDA’s draft guidance,” it said. “Further, a detailed assessment of 2,477 patients in REGENERATE, including nearly 1,000 patients on the study drug for at least four years, provides a well-characterized safety profile that is monitorable and manageable, and supports chronic administration of OCA.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome