Posts Tagged ‘serelaxin’

May 16th, 2014

FDA Turns Back Novel Drug for Acute Heart Failure

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

FDA Advisory Panel Recommends Against Approval of Novartis Heart Failure Drug

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

FDA Reviewers Recommend Against Approval for Novartis Heart Failure Drug

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) […]

June 27th, 2013

Novel Heart Failure Drug from Novartis Gains ‘Breakthrough Therapy’ Designation from FDA

Serelaxin, the novel therapy under development for the treatment of acute heart failure, has received a “breakthrough therapy” designation from the FDA, according to Novartis, the company developing the drug. The designation, the FDA explains, “is intended to expedite the development and review of drugs for serious or life-threatening conditions” and requires “preliminary clinical evidence that demonstrates the […]

January 7th, 2013

Selections from Richard Lehman’s Literature Review: January 7th

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

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 […]