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US FDA deems Novartis' heart failure candidate a 'breakthrough'

Serelaxin demonstrates ability to reduce shortness of breath and lower chance of dying

Novartis building

The US Food and Drug Administration (FDA) has recognised that Novartis' serelaxin could be an important step change in acute heart failure (AHF) therapy by granting it 'breakthrough' status.

Anticipation has been growing about serelaxin (RLX030) in recent months following the release of data from the 1100-patient RELAX-AHF study, which found the drug achieved a number of benefits in AHF patents including reduced shortness of breath and a lower chance of dying from any cause.

If approved, serelaxin has the potential to be the first treatment breakthrough for AHF patients in 20 years, according to Novartis, which also received breakthrough designation for its lung cancer drug LDK378 earlier this year. The company filed for approval of serelaxin in Europe last December and in the US earlier this year.

Breakthrough status was created by last year's FDA Safety & Innovation Act (FDASIA) and is intended to expedite the development and review of drugs that show substantial improvement over existing therapies, for example by reducing the number of patients needed in trials and elevating access to FDA staff during the development process.

Serelaxin is a recombinant version of the hormone relaxin which provides a number of beneficial cardiovascular effects during pregnancy, for example by causing blood vessels to dilate and lowering the resistance to blood being pumped from the heart to the body. It also seems to boost kidney function and cardiac output.

The RELAX-AHF data was first unveiled at the American Heart Association (AHA) annual meeting in Los Angeles last November and showed that Novartis' drug was associated with a 19 per cent improvement in shortness of breath (dyspnoea) compared to placebo.

There were also significant improvements in symptoms of AHF, the proportion of patients whose AHF worsened, reduced use of supportive drugs such as intravenous diuretics and shorter intensive therapy unit (ITU) stays with serelaxin.

Survival data from the study also showed a significant benefit on both cardiovascular and all-cause mortality (reduced by 37 per cent at six month), although the robustness of that finding has been open to debate given the relatively small number of patients and clinical events from the trial.

If additional follow-up validate the mortality findings it could prompt widespread use of the drug in just about any patient presenting at hospital with acute decompensated heart failure, which equates to around two million people a year in the US and Europe alone.

At the moment these patients have few treatment options beyond supportive care, and no drug to date has been shown to affect the course of heart failure. Almost a quarter of those who are hospitalised with AHF die within a year, and if approved serelaxin is expected to reach around $600m in annual sales within the first three years of launch.

Novartis is conducting a dedicated phase III trial with mortality as a primary endpoint, which could allow it eventually to put a survival claim on the label and drive sales above the $1bn mark.

Meanwhile, Novartis should also have data next year from a compound called LCZ696, an angiotensin receptor neprilysin inhibitor, which is the first in a new class for the treatment of chronic heart failure.

21st June 2013

From: Research, Sales

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