Drugs

FDA Reviewers Doubt Reata Kidney Drug’s Effectiveness

FDA reviewers have cast doubt on the effectiveness of Reata Pharmaceuticals’ bardoxolone to slow the loss of kidney function in Alport syndrome (AS) patients and reduce the risk of kidney failure with chronic use. In a briefing document released ahead of a 12/8 Cardiovascular and Renal Drugs Advisory Committee meeting, they say the company’s CARDINAL Phase 3 study did meet its prespecified primary and key secondary endpoints, which assessed on-treatment and off-treatment changes in estimated glomerular filtration rate (eGFR), but “[a] key review issue is whether the observed effects on eGFR indicate that bardoxolone slows the loss of kidney function in patients with [chronic kidney disease] CKD caused by AS.” The document further says that “[i]n addition to the concerns with CARDINAL Phase 3, there are no data in this application from an animal model of Alport syndrome or other adequate and well-controlled clinical trials in AS or CKD that show that bardoxolone slows the loss of kidney function.”

Specifically, the agency is seeking input from advisory committee members on:

Whether the observed effects on kidney function are indicative of an effect on disease progression in patients with AS (i.e., that bardoxolone slows the loss of kidney function or has any effect beyond a reversible, PD effect on kidney function)
Whether it is reasonable to conclude, based on the available data, that bardoxolone, when used chronically, will reduce the risk of progression to kidney failure in patients with AS

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