Drugs

Lilly Filing NDA for Expanded Tirzepatide Use

Eli Lilly says it will file an NDA mid-year for tirzepatide and its use in treating obstructive sleep apnea (OSA) based on just-announced data from the SURMOUNT-OSA Phase 3 clinical trials that showed tirzepatide injection (10 mg or 15 mg) significantly reduced the apnea-hypopnea index (AHI) compared to placebo. Tirzepatide is the active ingredient in the company’s Zepbound for treating chronic weight management.

AHI records the number of times a person’s breathing shows a restricted or complete block of airflow per hour of sleep and is used to evaluate OSA severity and treatment effectiveness, the company says. In the study, tirzepatide led to a mean AHI reduction from baseline of 27.4 events per hour compared to 4.8 events per hour for placebo-treated patients, it says. In a key secondary outcome, tirzepatide led to a mean body weight reduction of 18.1% from baseline, compared to 1.3% from baseline for placebo.

Lilly says tirzepatide’s overall safety profile was similar to previously reported trials, with the most commonly reported adverse events being gastrointestinal-related and generally mild to moderate in severity (diarrhea, nausea, vomiting and constipation).

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