Drugs

Panel Votes Down Intarcia Diabetes Implant

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee 9/21 voted 19 to 0 against approving Intarcia Therapeutics’ implantable ITCA 650 (exenatide in DUROS device), indicated for improving glycemic control in adults with Type 2 diabetes, because the implantable drug-device combination’s benefits do not outweigh its risks.

In voting down the product, panel members agreed with FDA reviewers’ assessment that risks of acute kidney injury are too worrisome. A briefing document released in advance of the panel meeting noted that CDER has repeatedly communicated this assessment to the company and in a 3/9/2020 complete response letter recommended that Intarcia “redesign the product such that it provides reliable and clinically appropriate exenatide release rates over the life of the product” and “conduct new clinical trials to demonstrate the efficacy and safety of the redesigned drug/device combination product.” However, following a CDER 7/29/2022 proposed order to deny approval of the NDA, the company requested a public hearing before an advisory committee, leading to this committee session.

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