Phase III DAPA-HF trial of Farxiga shows efficacy in heart failure.- AstraZeneca
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The FDA is alerting health care providers to no longer implant end-stage heart failure patients with Medtronic’s Heartware Ventricular Assist Device (HVAD) System due to a growing body of observational clinical comparisons that demonstrates a higher frequency of neurological adverse events and mortality associated with the system when compared to other commercially available devices, as well as complaints that the internal pump may delay or fail to restart.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended vericiguat, a soluble guanylate cyclase (sGC) stimulator, for marketing authorization in the European Union. Once approved, the use of vericiguat (2.5 mg, 5 mg, and 10 mg) will be authorized for the treatment of symptomatic chronic heart failure in adult patients with reduced ejection fraction who are stabilised after a recent decompensation event requiring intravenous (IV) therapy.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted a positive opinion recommending Jardiance (empagliflozin) for the treatment of adults with symptomatic chronic heart failure with reduced ejection fraction (HFrEF), Boehringer Ingelheim and Eli Lilly and Company announced “Heart failure is a progressive and debilitating condition affecting 60 million people worldwide. It is the leading cause of hospitalizations in Europe – not only impacting the quality of life considerably for those living with the condition but also putting significant pressure on healthcare systems,” said Faiez Zannad, M.D., Ph.D., EMPEROR Program clinical investigator and Emeritus Professor of Therapeutics at the University of Lorraine, France.