May 16th, 2014
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. The FDA decision was not unexpected since earlier this […]
March 27th, 2014
The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted unanimously (11-0) against approval of the biologics license application (BLA) for serelaxin (proposed trade name, Reasanz). The novel drug from Novartis was intended to be used in patients with acute heart failure (HF). The once highly promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval […]
March 25th, 2014
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) […]
December 23rd, 2013
This week’s topics include dual-antiplatelet therapy after zotarolimus-eluting stents, low-dose dopamine or low-dose nesiritide in acute HF with renal dysfunction, and more.
January 7th, 2013
This week’s topics include a study of survival among patients receiving a primary prevention ICD in clinical practice vs. clinical trials and the RELAX-AHF trial, which examined treatment of acute HF with serelaxin.
September 25th, 2012
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 […]
November 14th, 2010
ASCEND-HF (Acute Study of Clinical Effectiveness of Nesiritide in Decompensated Heart Failure Trial) was started in response to the enormous controversy over the safety and efficacy of nesiritide, which was being used in growing numbers of heart failure patients. The trial randomized 7141 patients with acute, decompensated HF to receive standard therapy and either continuous intravenous nesiritide or placebo. Results of ASCEND-HF, presented as a […]