Drugs

CDER Hearing Delay on NDA is ‘Unfounded’: Lexicon

Lexicon Pharmaceuticals says a CDER proposed order to delay a hearing and deny approval of the company’s NDA for sotagliflozin oral tablets to treat Type 1 diabetes mellitus (T1DM) “is unfounded based on the facts of the data presented by Lexicon: an effective drug for TIDM, with additional efficacy benefits in terms of weight and blood pressure reduction, is being denied on the basis of a DKA (diabetic ketoacidosis) that can be mitigated and managed through a REMS and other measures that healthcare providers and patients are already familiar with and utilizing.” Lexicon’s position is stated in its 11/28 response to the proposed CDER order.

The company says that for a patient population with limited treatment options other than injectable insulin, “sotagliflozin would provide another option in the armamentarium of managing a chronic and burdensome disease.”

Lexicon asks that its NDA for the 200 mg dose be approved with a REMS or a hearing be scheduled to resolve the “numerous genuine and substantial issues of fact regarding the approval of” the NDA.

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