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Top stories in cardiology: FDA warns Mylan for manufacturing violations, panel supports icosapent ethyl for CV risk reduction
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The FDA’s warning to Mylan Laboratories Limited for violations of good manufacturing practices in response to an inspection conducted at one of the company’s drug manufacturing facilities in India was one of the week’s top stories in cardiology.
News that the FDA’s Endocrinologic and Metabolic Diseases Advisory Committee voted in support an indication for icosapent ethyl to reduce risk for cardiovascular events was another top story.
FDA warns Mylan over valsartan manufacturing violations
The FDA announced it issued a warning letter to Mylan Laboratories Limited over violations of current good manufacturing practice observed during an inspection of a drug manufacturing facility in India. Read more.
FDA panel unanimously supports CV event risk reduction indication for icosapent ethyl
The Endocrinologic and Metabolic Diseases Advisory Committee of the FDA voted 16-0 in favor of the safety and efficacy of icosapent ethyl, based on available data, to support its approval for an indication to reduce risk for CV events. Read more.
Apple Heart Study publication offers further insights on AF detection from wearables
Results of the Apple Heart Study that were presented earlier this year at the American College of Cardiology Scientific Session have been published in The New England Journal of Medicine. Read more.
‘Obesity paradox’ present for all-cause mortality regardless of increased HF risk
Despite an increased risk for HF among patients with obesity, there was a paradoxical decline in all-cause mortality, according to a meta-analysis published in Heart. Read more.
Lipid levels decreased since publication of 2013 cholesterol guidelines
Lipid and lipoprotein levels have declined since the 2013 American College of Cardiology/American Heart Association cholesterol guidelines were published, according to a study published in the Journal of the American College of Cardiology. Read more.