Drugs

Clinical Hold Placed on Zafgen Diabetes Therapy

FDA has placed a clinical hold on a Zafgen clinical trial of ZGN-1061, the company’s second-generation, investigational MetAP2 inhibitor currently in development for treating Type 2 diabetes. The agency cited the possibility of cardiovascular (CV) safety risk based on the company’s prior compound and outlined multiple paths to move forward, including nonclinical or clinical options that could address the concern, Zafgen says. The company scrapped its first-generation MetAP2 inhibitor beloranib after reporting in 2015 a second death in a trial involving patients with Prader-Willi syndrome.

Zafgen plans to assess the FDA options and request a Type A meeting with the agency to discuss next steps with the program. The company also says it continues to advance its ongoing outside-the-U.S. Phase 2 clinical trial of ZGN-1061, which includes a 1.8 mg dose cohort. Dosing in this clinical trial, it says, was recently completed and no CV safety signals have been observed to date. The company expects to report topline data from this cohort in early 2019.

MetAP2 inhibitors work by re-establishing balance to how the body packages and metabolizes fat, Zafgen says. “Inhibitors of MetAP2 reduce the production of new fatty acid molecules by the liver and help to convert stored fats into useful energy,” it adds.

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