Reuters: Regulatory News: Novartis heart failure drug effective across patient groups

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Novartis heart failure drug effective across patient groups Sep 2nd 2013, 12:00 Mon Sep 2, 2013 8:00am EDT * Serelaxin works across sub-groups, study results show * Heart failure drug viewed as potential blockbuster By Ben Hirschler AMSTERDAM, Sept 2 (Reuters) - An experimental drug from Novartis to treat heart failure proved equally effective regardless of the age of patients or whether they had other medical problems, clinical trial results presented on Monday showed. The drug, serelaxin, which is a form of a human hormone that relaxes blood vessels and eases stress on the heart and other organs, is viewed as an important medicine in the Swiss drugmaker's developmental pipeline. Analysts at Jefferies expect the drug to generate peak sales of $1.5 billion a year. Results from a Phase III study last November found it reduced deaths by 37 percent compared with placebo - and the latest data offers further insight by showing how it performed in different patient sub-groups. The drug led to reduced dyspnea, or breathlessness, and fewer deaths after six months in all patient groups, including those with impaired kidney function, those aged 75 or older, and those with atrial fibrillation, or irregular heartbeats. The new findings were presented at the European Society of Cardiology congress in Amsterdam, where heart doctors have highlighted the enormous need for new treatments for acute heart failure, in which the heart is unable to pump enough blood. Some 2 million patients are hospitalised each year in Europe and United States as a result of heart failure, and about half of all patients die within five years of being diagnosed with the condition. Medical treatment of heart failure has changed little since the 1970s but Novartis hopes serelaxin will soon offer cardiologists a new therapy option. U.S. regulators in June gave serelaxin "breakthrough therapy" status, potentially fast-tracking its development and approval. The Novartis drug is currently being assessed by health authorities around the world, including the U.S. Food and Drug Administration and the European Medicines Agency. Novartis previously disclosed that while serelaxin met one of the study's two primary goals by reducing deaths and relieving dyspnea, it failed to hit a secondary combined objective of lowering cardiovascular death and reducing the need for patients to go back into hospitals. Researchers view the life-saving benefit as the more important measure, although many still want to see further evidence of the drug's performance given past disappointments in the field. Link this Share this Digg this Email Reprints

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