Drugs

Reviewers Raise Sotagliflozin Issues

FDA medical reviewers are raising safety issues associated with Sanofi’s sotagliflozin that will be considered by the agency’s Endocrinologic and Metabolic Drugs Advisory Committee 1/17. A briefing document released in advance of the meeting says Sanofi is seeking approval for the drug as an adjunct to insulin therapy to improve glycemic control in adults with Type 1 diabetes.

The document says sotagliflozin is an orally administered inhibitor of both sodium-glucose co-transporter 1 and sodium-glucose co-transporter 2. It does not alter the underlying pathophysiology of Type 1 diabetes but lowers plasma glucose by increasing urinary glucose excretion.

The drug’s development program studied 200 mg and 400 mg doses that Sanofi proposes to market.

The medical reviewers say 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,” the report says.

Advisory committee members are asked to discuss the benefits claimed by Sanofi and the strength of the statistical evidence and clinical meaningfulness of each of the claimed benefits; the level of concern about the risk of DKA; the relative differences in efficacy and/or safety between the two proposed doses; the clinical meaningfulness of a composite endpoint used by Sanofi; and the benefit/risk calculation for the drug.

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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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