Drugs

Lilly Once-Weekly Insulin Injection Approved

FDA has approved Eli Lilly’s Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for controlling high blood sugar in adults with Type 2 diabetes when used along with diet and exercise. Onswik is designed to deliver steady basal insulin levels over a full seven days, the company says.

Approval was based on data from the QWINT Phase 3 clinical trials, which evaluated the safety and efficacy of once-weekly Onswik in over 3,400 adults with Type 2 diabetes. “In each QWINT trial, once-weekly Onswik met the primary endpoint of non-inferior A1C reduction from baseline that was comparable to insulin glargine U-100 (glargine) or insulin degludec U-100 (degludec),” the company says.

Lilly adds that the trials demonstrated an overall safety profile similar to the daily basal insulins studied. Common side effects observed include low blood sugar, allergic reactions, reactions at the injection site, skin thickening or pits at the injection site (lipodystrophy), itching, rash, swelling of hands and feet, and weight gain.

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