Drugs

Lilly’s Lyumjev OK’d for Insulin Pump

FDA has approved Eli Lilly’s rapid-acting insulin Lyumjev (insulin lispro-aabc injection) 100 units/mL, indicated for improving glycemic control in adults with Type 1 and Type 2 diabetes, to include administration through continuous subcutaneous insulin infusion with an insulin pump. Lyumjev, a novel formulation of insulin lispro developed to speed the absorption into the bloodstream and reduce A1C levels, was originally approved 6/2020. “As a rapid-acting mealtime insulin, Lyumjev helps control blood sugar levels after meals in adults with diabetes, similar to how natural insulin works after meals in people without diabetes,” the company says.

Approval was based on results from PRONTO-PUMP-2, a Phase 3 treat-to-target study that confirmed the efficacy and safety of Lyumjev when used in insulin pumps in adults with Type 1 diabetes, Lilly says. The study met the primary endpoint of noninferior A1C reduction from baseline to week 16 compared to Humalog, it says, adding that Lyumjev demonstrated superior reduction in blood glucose spikes at both one and two hours after a test meal compared to Humalog.

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