Drugs

Advisors Back Ardelyx’ Kidney Disease Drug

Members of the FDA Cardiovascular and Renal Drugs Advisory Committee 11/16 voted 9-4 to back Ardelyx’ tenapanor as a monotherapy in kidney disease patients and 10-2-1 for its use in combination with phosphate binders. FDA medical reviewers had raised concerns about the drug’s treatment effect in a complete response letter, in response to two company appeals, and in a briefing document circulated before the advisory committee meeting.

The agency had asked committee members to consider tenapanor’s benefits and risks for controlling phosphorous levels in dialysis patients with chronic kidney disease. FDA now has 30 days to respond to the company’s latest appeal of the agency’s complete response letter.

Committee members said they would welcome more data, especially from studies that measure the clinical outcomes of reducing phosphorous levels, according to BioPharmaDive, but ultimately said they believed that tenapanor was effective and could benefit patients by allowing them to take one tablet twice a day.

Ardelyx currently markets tenapanor as Ibsrela with an indication to treat irritable bowel syndrome. If FDA approves the NDA, it will market it as Xphozah for kidney patients.

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