Drugs

Panel Rejects Lexicon Pharma Diabetes Drug

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee 10/31 voted 11 to 3 against recommending approval for Lexicon Pharmaceuticals' drug Zynquista (sotagliflozin) as an adjunctive treatment to insulin for adults with Type 1 diabetes and chronic kidney disease. The committee's primary concern centered on safety, specifically the risk of diabetic ketoacidosis (DKA), a serious and often life-threatening consequence of insulin insufficiency. A previous submission sought an indication as an adjunct to insulin to improve glycemic control in adults with Type 1 diabetes, but that was denied in a 2019 complete response letter, which cited deficiencies such as data demonstrating that the addition of sotagliflozin to insulin is associated with an increased risk of DKA.

Despite obtaining approval for Zynquista in Europe in 2019, Lexicon has struggled to secure FDA approval stateside due to these ongoing safety concerns. Two subsequent dispute resolution requests were rejected by CDER based on a determination that the drug’s DKA risk outweighed its benefits.

FDA has set a 12/20 user fee review action target date for the current submission.

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