Drugs

FDA Eliminates CV Outcomes Data on Diabetes Drugs

FDA has issued a new draft guidance on “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control” that proposes to remove a previous recommendation that sponsors of all new therapies for Type 2 diabetes uniformly rule out risks for ischemic cardiovascular adverse outcomes (cardiovascular outcome trials). It recommends broad pre-approval safety evaluations that examine beyond ischemic (reduced blood flow) cardiovascular disease. The guidance also proposes a broader scope of human subjects, such as older subjects and those with chronic kidney disease who may be more vulnerable to drug-related side effects, to include in clinical trials.

“By following previous FDA recommendations, sponsors have shown that new Type 2 diabetes drugs do not have excess ischemic cardiovascular risk, which has provided reassuring cardiovascular safety information for millions of diabetes patients,” the agency says in announcing the proposed recommendations. “Now, with this proposed approach, we will have broader, valuable safety information for these medications.” The policy shift was supported by FDA’s Endocrinologic and Metabolic Drugs Advisory Committee, which noted safety data beyond ischemic cardiovascular safety data was desired to evaluate the safety profile of antidiabetic drugs before they were approved.

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