Drugs

FDA Questions Ardelyx’ Tenapanor

In a briefing document released in advance of an 11/16 meeting of the Cardiovascular and Renal Drugs Advisory Committee, FDA medical reviewers continue to raise questions about the Ardelyx NDA for tenapanor to control serum phosphorous in adults with chronic kidney disease on dialysis. The document says the agency issued a complete response letter to the NDA on 7/28/21 citing questions about the magnitude and clinical significance of the drug’s treatment effect. Following a meeting with FDA to discuss the letter, Ardelyx pursued two formal dispute resolution requests. The second request resulted in a referral to the advisory committee.

A chart in the briefing paper lays out the reviewers’ evidence and uncertainties about the drug’s benefit/risk framework when compared to existing treatment options. The paper also has several draft points for the committee’s consideration involving the level of the treatment effect of tenapanor as monotherapy and in combination with existing phosphate binder treatment. The advisors were also asked to comment on the safety and tolerability of diarrhea as the most common adverse reaction. Finally, they were asked to weigh whether the drug’s benefits outweigh its risks, both when administered as monotherapy and in combination with other agents.

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