Drugs

Lexicon Loses Appeal of FDA ‘Complete Response’

FDA’s Office of New Drugs has denied a Lexicon Pharmaceuticals appeal of a March Complete Response Letter on its NDA for Zynquista (sotagliflozin), a dual SGLT1 and SGLT2 inhibitor for adults with Type 1 diabetes in combination with insulin. Without disclosing FDA’s concerns, the company says the agency reiterated its prior position denying the appeal. Lexicon says it intends to appeal the decision to CDER’s Office of the Director.

In January, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee was spit 8 to 8 on whether the overall benefits of Zynquista (sotagliflozin) outweighed the risks to support approval. Panel members were concerned about a safety signal that FDA raised in a briefing document released in advance of the meeting. Medical reviewers said a serious adverse event for sotagliflozin is the consistent and clinically meaningful increase in the risk of diabetic ketoacidosis (DKA) compared to placebo observed in all three Phase 3 clinical trials. “While all patients with Type 1 diabetes may to some degree be at risk for DKA, sotagliflozin therapy clearly increases that risk, and the risk may be unpredictable,” they said.

The companies offered FDA a risk management plan that included doctor and patient education (including emphasis on more frequent testing and recognizing early signs of DKA), but some panel members expressed concern that this could be inadequate in a real-world setting.

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