Drugs

Ardelyx Continuing Tenapanor Appeal

Ardelyx says it received 2/4 an appeal denied letter (ADL) from the FDA Office of Cardiology, Hematology, Endocrinology, and Nephrology, and will appeal that decision to the Office of New Drugs. In an SEC filing, the company says it had submitted a formal dispute resolution request early in 12/2021 following receipt of a 7/28/21 complete response letter (CRL) for its NDA for tenapanor to control serum phosphorus in chronic kidney disease patients on dialysis.

According to Ardelyx, the request for formal dispute resolution was focused on demonstrating that the data submitted in the NDA supported the clinical significance of the drug’s treatment effect. The CRL had said that for the NDA to be approved, the company would need to conduct an additional clinical trial demonstrating a clinically relevant treatment effect on serum phosphorous or an effect on the clinical outcome thought to be caused by hyperphosphatemia in chronic kidney disease patients on dialysis.

Ardelyx says the ADL gave it a potential path forward involving the resubmission of the NDA with some new analyses of each of the Phase 3 trials, an assessment of tenapanor’s risks and benefits, and a proposal for how to label tenapanor for prescribers, all without conducting an additional trial.

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