Drugs

Cytokinetics Reports Exercise Data on Heart Drug

Cytokinetics says topline results from its Phase 3 MAPLE-HCM clinical trial demonstrated that investigational drug aficamten significantly improved exercise capacity in patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM) when used as a stand-alone treatment. The study compared aficamten to metoprolol, a standard beta blocker therapy.

According to the company, the trial met its primary endpoint, showing a statistically significant improvement in peak oxygen uptake (pVO2) over a 24-week period in patients treated with aficamten. The safety and tolerability profile of aficamten was also favorable compared to metoprolol, it says.

Cytokinetics says the trial’s full results will be presented at an upcoming medical conference.

Aficamten is described as a selective, small molecule cardiac myosin inhibitor designed to reduce the number of active actin-myosin cross bridges during each cardiac cycle and consequently suppress the myocardial hypercontractility that is associated with HCM.

An NDA for aficamten for treating patients with obstructive hypertrophic cardiomyopathy is under review with a decision expected by 12/26.

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