Drugs

FDA Extends Review of Sanofi’s iGlarLixi Over ‘Pen’ Concerns

FDA has extended by three months its review of a Sanofi NDA for iGlarLixi (insulin glargine and lixisenatide) injection, indicated for improving glycemic control in adults with Type 2 diabetes mellitus. Sanofi has submitted updated information on the pen delivery device to address concerns from an advisory committee that reviewed the submission in May. The submission of the additional information is viewed as a major amendment, and the new user fee review target is now expected by late November. In July, lixisenatide was approved by FDA as a monotherapy under the brand name Adlyxin for treating Type 2 diabetes.

In May, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 12 to 2 to recommend approval for iGlarLixi, but several panel members expressed concern with the pen administration device used to deliver the medications. Specifically, they were concerned that pen’s design was confusing and could lead to dosing errors. They urged the agency and the company to address these issues prior to approving 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