FDA Rejects Novel Novartis Drug For Acute Heart Failure Reply

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 on Forbes.

 

 

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FDA Advisory Panel Recommends Against Approval Of Novartis Heart Failure Drug Reply

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. The once highly-promising drug, which received a ”breakthrough therapy” designation from the FDA last year, was also turned down for approval in Europe earlier this year.

Click here to read the entire post on Forbes.

 

 

FDA Reviewers Recommend Against Approval For Novartis Heart Failure Drug 1

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) for serelaxin injection (proposed trade name Reasanz) from Novartis.

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European Setback For Novartis Heart Failure Drug Reply

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 was published in the Lancet in 2012. Here is CHMP’s explanation for their decision:

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FDA Advisory Panel To Review New Heart Failure Drug From Novartis Reply

A novel acute heart failure drug from Novartis will be evaluated next month by an FDA advisory committee, perhaps countering a long string of crash-and-burn cardiology drugs. On February 13 the FDA’s Cardiovascular and Renal Drugs Advisory Committee will discuss the biologics license application (BLA) for serelaxin injection from Novartis. The indication is for the improvement of the symptoms of acute heart failure through reduction of the rate of worsening of heart failure. (The meeting notice has been posted in the Federal Register but has not yet appeared on the FDA website.) Last year the drug received a “breakthrough therapy” designation from the FDA.

Click here to read the full post on Forbes.

 

Novel Heart Failure Drug From Novartis Gains ‘Breakthrough Therapy’ Designation From FDA 1

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 drug may have substantial improvement on at least one clinically significant endpoint over available therapy.” In addition to getting a speedier review process, the sponsor of a drug with the designation receives “more intensive FDA guidance” on the development program.

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Richard Lehman On ICDs In Clinical Practice And Serelaxin For HF Reply

This week in CardioExchange Richard Lehman is not quite as funny as most weeks (perhaps he’s still recovering from New Years’ celebrations?), but he has some interesting and useful comments on a JAMA study comparing real world patients garcinia cambogia plant uses in registries to patients in clinical trials and an impressive Lancet study testing the role of the novel agent serelaxin in acute heart failure.

“So after much hard work and statistical legerdemain, the study shows that the mortality of real-life heart failure patients after ICD implantation for primary prevention is the same as that in the trials, and less than that of the control patients in the trials. Which I guess is a useful thing to know.”

….

 “I don’t think that by itself it changes practice in any way, but it does show that recombinant human relaxin 2, serelaxin, is an interesting new treatment that deserves further study in heart failure.”

RELAX-AHF Stirs Interest In Novel Drug For Acute Heart Failure Reply

A new drug modelled on a hormone active in pregnancy may prove beneficial to patients with acute decompensated heart failure. Serelaxin is a recombinant form of human relaxin-2, which is known to mediate the hemodynamic changes that occur during pregnancy. The drug is under development by Novartis for use in acute heart failure.

In the RELAX-AHF trial, 1,161 patients were randomized to serelaxin or placebo in the first hours of acute decompensated heart failure. Results of the trial, presented by John Teerlink at the American Heart Association in in Los Angeles and published simultaneously in the Lancet, have sparked considerable interest in the heart failure community, since few options have proven successful in this setting.

RELAX-AHF had co-primary endpoints. For the first primary endpoint, dyspnea relief  through day 5 (as measured by the visual analog scale area under the curve), serelaxin was associated with a statistically significant 19.4% improvement, resulting in a mean difference of 448 mm per hour (p=0.0075). The trial therefore reached the prespecfied criterion for efficacy. However, there were no significant differences in the other primary endpoint, dyspnea relief at 24 hours. There were also no significant differences in the secondary endpoints of cardiovascular death or hospital readmission for heart failure or renal failure through day 60.

At six months, however, cardiovascular deaths were significantly reduced in the serelaxin group:

  • 9.5% (55) in the placebo group versus 6% (35) in the serelaxin group (HR 0.63, CI 0.41-0.96, p=0.028, NNT = 29)

The investigators also reported that serelaxin was associated with significant reductions in the signs and symptoms of congestion at day 2, fewer patients with worsening heart failure, and the use of lower doses of IV diuretics.

The results, concluded the authors, “provide supportive evidence for a beneficial effect of serelaxin improving symptoms and other clinical outcomes in selected patients with acute heart failure.” The trial discussant, John McMurray, said that he believed serelaxin “does improve dyspnea and other symptoms and signs of congestion” but wondered about the clinical significance of the magnitude of the improvement and, also, whether the single trial would be sufficient to gain marketing approval.

A Surprising Reduction In Mortality

McMurray, along with trial investigators and other heart failure experts present at the AHA, expended considerable energy thinking about the reduction in mortality. The Lancet authors acknowledged that the findings of a six month survival benefit “for a drug given for 48 h with a moderate number of death events (107 total) raises the question of whether this benefit is due to chance and whether another, confirmatory trial should be done.” McMurray noted that if only two deaths had moved from one group to the other then the mortality finding would not have been significant.

But at an AHA news conference Milton Packer emphasized that “if the mortality effect is true then this trial changes the way we do things.” If confirmed, he said, it would mean that cardiologists would need to treat acute heart failure patients like ACS patients and deliver immediate treatment. Other heart failure cardioloigsts, including Mariel Jessup and Greg Fonarow, agreed that the mortality finding, if confirmed, would mean that serelaxin treatment would represent a genuine breakthrough in the treatment of acute heart failure. But, said Packer, “the real question is whether the mortality difference seen in this trial is true and replicable.”

Click here to read the AHA press release…