Drugs

Trial Success for Lilly Oral GLP-1

Lilly says its oral GLP-1 investigational drug orforglipron demonstrated superior glycemic control in the Phase 3 ACHIEVE-2 and ACHIEVE-5 trials. A company statement says ACHIEVE-2 was the second head-to-head trial that evaluated orforglipron versus dapagliflozin (AstraZeneca’s Farxiga), an SGLT-2 inhibitor, in adults with Type 2 diabetes inadequately controlled on metformin. ACHIEVE-5 evaluated orforglipron versus placebo in adults with Type 2 diabetes and inadequate glycemic control with titrated insulin glargine, with or without metformin and/or SGLT-2 inhibitors.

The company says that in both trials, the overall safety and tolerability profile of orforglipron and treatment discontinuation rates were consistent with earlier studies.

The most common adverse events were gastrointestinal-related and generally mild to moderate in severity, the statement says. No hepatic safety signal was seen.

Orforglipron is described as a once-daily small molecule oral glucagon-like peptide 1 receptor agonist that can be taken any time of the day without restrictions on food and water intake.

Lilly says it is running Phase 3 studies on the drug to treat Type 2 diabetes and for use in weight management in adults with obesity or overweight with at least one weight-related medical problem. It also is being studied as a potential treatment for obstructive sleep apnea, hypertension, and osteoarthritis pain in adults with obesity, Lilly says.

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