Drugs

Esperion Reports Positive Phase 3 Results for Cholesterol Drug

Esperion has reported positive top-line results from a pivotal Phase 3 study (Study 4 or 1002-048) involving its investigational bempedoic acid 180 mg. The trial was designed to evaluate the LDL-C lowering efficacy and safety and tolerability of bempedoic acid versus placebo in patients with, or at high risk for, atherosclerotic cardiovascular disease. The 12-week study met its primary endpoint with LDL-C, with the bempedoic acid group seeing a 23% reduction compared to a 5% LDL-C increase for the placebo group. “Patients treated with bempedoic acid also achieved a significantly greater reduction of 33% in high-sensitivity C-reactive protein, an important marker of the underlying inflammation associated with cardiovascular disease, compared to the placebo group which had an increase of two percent (p<0.001),” the company says.

In the study, bempedoic acid was shown to be safe and well-tolerated, Esperion said. Adverse events reported were similar between the bempedoic acid group and the placebo group, it added.

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