Drugs

Diabetes Cardiovascular Risk Guidance Committee Meeting

Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee will meet 10/24-25 to discuss the agency’s 2008 guidance “Diabetes Mellitus—Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.” An agency briefing document distributed in advance of the session says that concerns were raised in the past that treatment of patients with diabetes was too “glucocentric” and that there may be therapies that lower blood glucose but also increase the risk for adverse cardiovascular events.

The document says the 2008 guidance was issued to ensure that new antidiabetic therapies to treat Type 2 diabetes were not associated with an unacceptable increase in cardiovascular risk, and the guidance’s recommendations were applied to all new drug products intended to treat Type 2 diabetes, regardless of whether a signal of concerns was identified in the development program. Over the past decade, cardiovascular risk assessments for new antidiabetic drugs have been conducted in accordance with the guidance recommendations, the committee was told.

The document says that eight trials have been conducted under the guidance and all eight have demonstrated no excess cardiovascular risk, with some showing a reduced risk for adverse cardiovascular events. “Now that we have results of several trials and 10 years of experience with drug development under the guidance,” the document says, “it seems apropos to review what we have learned and consider what changes to the approach, if any, are necessary.”

The briefing document includes four points for discussion along with information on why the guidance was issued, a description of how things have changed as a result of the guidance, and what has been learned.

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