Drugs

Reviewers Question Intercept’s Liver Drug

FDA is asking the Gastrointestinal Drugs Advisory Committee to weigh the benefits and risks of Intercept Pharmaceuticals’ obeticholic acid (OCA) to treat pre-cirrhotic liver fibrosis due to nonalcoholic steatohepatitis (NASH). In a briefing document released in advance of the committee’s 5/19 meeting, agency medical reviewers say there are currently no approved medical treatments for NASH in the U.S.

The report says that in the pivotal trial, OCA 25 mg compared to placebo met only one of the two pre-specified primary endpoints, while the 10 mg dose failed to meet either endpoint. However, the reviewers write, “the adverse reactions experienced with OCA 25 mg suggest that treatment with this dose exacerbates co-morbidities or creates new ones for a patient population at risk for metabolic syndrome and its manifestations.”

The document lists six questions for the committee to discuss, ending with whether the members recommend approval of OCA 25 mg via the accelerated approval pathway based on a surrogate histologic marker.

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