–In RELAX-AHF-2 serelaxin didn’t improve clinical outcomes. Yet another promising drug for acute heart failure has failed to improve long-term outcomes. In the RELAX-AHF-2 trial 6,600 patients hospitalized for acute heart failure were randomized to a 48-hour infusion of serelaxin or placebo. There was no significant difference between the two groups in either of the…
Long-Term Benefit in HF Patients Elusive for Novel Vasodilator
November 13, 2016 by Leave a Comment
–Investigational drug ularitide had no effect on mortality or clinical outcomes NEW ORLEANS — Short term vasodilator treatment for acute heart failure in the hospital did not lead to long term clinical benefits in the largest and most rigorous trial in the field yet performed, researchers said. In the TRUE-AHF trial 2,157 patients with acute…
FDA Rejects Novel Novartis Drug For Acute Heart Failure
May 16, 2014 by Leave a Comment
Novartis said today that the FDA had issued a complete response letter for the biologics license application for RLX030. The drug, also known as serelaxin, is a recombinant form of the naturally occurring human hormone relaxin-2, which has been found to help women adjust to the cardiovascular changes that occur during pregnancy. … Click here to read the full post…
European Setback For Novartis Heart Failure Drug
January 24, 2014 by Leave a Comment
European regulators have dealt a setback to a novel heart failure drug under development by Novartis. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended against giving market approval to serelaxin (Reasanz) for the treatment of acute heart failure. The recommendation is based largely on the committee’s analysis of the RELAX-AHF trial, which…
Novartis Announces Top Line Results For Phase 3 Trial Of New Acute Heart Failure Drug
September 24, 2012 by Leave a Comment
Novartis 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…
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