CardioExchange Archive

March 25th, 2014

FDA Reviewers Recommend Against Approval for Novartis Heart Failure Drug

Larry Husten, PHD

Ahead of an important advisory panel FDA reviewers have recommended against approval of a novel drug for acute heart failure from Novartis. The once highly promising drug, which received a “breakthrough therapy” designation from the FDA last year, was turned down for approval in Europe earlier this year. On Thursday, the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) […]

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September 25th, 2012

Novartis Announces Top Line Results for Phase 3 Trial of New Acute Heart Failure Drug

Larry Husten, PHD

Novartis has announced preliminary results from the RELAX-AHF trial, a phase 3 study of a novel drug, RLX030 (serelaxin), for patients hospitalized with acute heart failure. The company said the trial met one of its two primary endpoints in reducing dyspnea. Novartis also reported a reduction in all-cause mortality at 6 months. However, it should be noted that the […]

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August 24th, 2010

Study Suggests Prognostic Power of Dyspnea in Acute Heart Failure

Larry Husten, PHD

Results of a study with the hormone relaxin suggest that a lack of ongoing dyspnea relief may be an important predictor of outcome. Marco Metra and fellow investigators in the Pre-RELAX-AHF study randomized 232 patients with acute heart failure to placebo or one of 4 doses of relaxin. Only 25% of all patients in the […]

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