Drugs

Novo Nordisk Files 2 Semaglutide NDAs

Novo Nordisk has submitted two NDAs to FDA for oral semaglutide, the first once-daily glucagon-like peptide-1 receptor agonist in a pill. The company says one NDA was submitted seeking approval as an adjunct to diet and exercise to improve blood sugar in adults with Type 2 diabetes. The company used a priority review voucher for this NDA and anticipates a six-month review time.

The second NDA seeks approval for an indication to reduce the risk of major adverse cardiovascular events in adults with Type 2 diabetes and established cardiovascular disease. It has an anticipated 10-month review time.

At the same time, Novo Nordisk submitted an sNDA for once-weekly Ozempic (semaglutide) injection seeking an indication to reduce risk of major adverse cardiovascular events in adults with Type 2 diabetes and established cardiovascular disease. Ozempic was approved 12/5/17 for adults with Type 2 diabetes to improve blood sugar along with diet and exercise.

The company says the efficacy and safety of oral semaglutide were evaluated in 10 PIONEER clinical trials including 9,543 adults with Type 2 diabetes. In the trials, people treated with oral semaglutide were compared to those taking sitagliptin, empagliflozin, liraglutide, and placebo.

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