Drugs

Advisors Back Novo Nordisk Diabetes Drug

Members of the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 16-0 on 5/24 to support the safety and efficacy of Novo Nordisk’s Xultophy (insulin degludec and liraglutide injection) for the proposed indication of adjunct to diet and exercise to improve glycemic control in treating adults with Type 2 diabetes. Xultophy is described as a fixed-dose combination of Victoza (liraglutide), a glucagon-like peptide-1 receptor agonist, and Tresiba (insulin degludec), a long-acting insulin analog.

Committee members generally indicated that the data supporting the drug’s efficacy were compelling and that no unexpected safety issues were seen in the clinical trials. One committee member reportedly suggested that FDA consider requiring a post-approval study evaluating Xultophy’s efficacy beyond 26 weeks. Also suggested was a post-approval study to assess weight reduction with treatment for 12 months or longer, and a study to help define patients in whom treatment is ineffective to better guide appropriate use of the product.

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