Drugs

Bayer: More Positive Kidney Disease Drug Data

Bayer is reporting positive data from a second Phase 3 study (FIGARO-DKD) that evaluated the safety and efficacy of finerenone versus placebo when added to standard of care in patients with chronic kidney disease (CKD) and Type 2 diabetes. FIGARO-DKD met its primary endpoint, demonstrating that finerenone significantly reduced the composite risk of time to first occurrence of cardiovascular (CV) death or non-fatal CV events (myocardial infarction, stroke, or heart failure hospitalization), according to the company.

In January, FDA accepted for priority review a Bayer NDA for finerenone based on data from the first Phase 3 trial (FIDELIO-DKD). Finerenone is described by the company as a potential first-in-class investigational, non-steroidal, selective mineralocorticoid receptor antagonist that has demonstrated positive kidney and cardiovascular outcomes in patients with CKD and Type 2 diabetes.

Meanwhile, Bayer has begun the Phase 3 FINEARTS-HF study, which will investigate finerenone compared to placebo in more than 5,500 patients with symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction greater than 40%. The study aims to demonstrate finerenone’s superiority over placebo in reducing the rate of the composite endpoint of cardiovascular death and total (first and recurrent) heart failure events.

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