Drugs

Lilly Reports Positive Data in Weekly Insulin Trials

Eli Lilly says data from its QWINT-1 and QWINT-3 Phase 3 clinical trials evaluating once-weekly insulin efsitora alfa in adults with Type 2 diabetes showed non-inferiority A1C reduction compared to the most frequently used daily basal insulins. The trials evaluated the therapy in patients using basal insulin for the first time and in those who have switched from daily basal insulin injections.

“Once weekly insulins, like efsitora, have the potential to transform diabetes care as we know it,” the company says. “Many patients are reluctant to start insulin because of the burden it places on them. With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives.”

The trial data showed that the primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 52 was met, according to Lilly. “For the efficacy estimand, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine, resulting in an A1C of 6.92% and 6.96%, respectively,” it says.

Regarding safety, Lilly says that in both QWINT-1 and QWINT-3, efsitora’s overall safety and tolerability profile was comparable to that of daily basal insulin therapies. It plans to share more detailed data at an upcoming medical meeting and in a peer-reviewed journal.

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