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FDA panel rejects Novartis' heart failure hope serelaxin

Decision follows EMA knock back earlier this year

Novartis building

An FDA advisory committee voted unanimously against approval of Novartis' acute heart failure (AHF) candidate serelaxin yesterday, although the company says it will stick with the project.

As predicted, the panel agreed with the position taken by the FDA reviewers, saying more data was needed to prove serelaxin improves symptoms such as shortness of breath (dyspnoea) and slows the rate of worsening AHF after hospitalisation.

They also pointed out that the drug - which has the proposed trade name of Reasanz - did not appear to have any effect on other AHF symptoms, including cough, anxiety and fatigue.

Novartis filed for approval of serelaxin on the strength of one clinical trial called RELAX-AHF, and while some of the panellists seemed to suggest serelaxin's effect on symptoms was probably real, limitations in the design of the study and gaps in the data made it impossible to say that with any degree of certainty.

The vote suggests that Novartis will almost certainly have to bit the bullet and complete a confirmatory clinical trial of serelaxin, although the FDA still has to deliver its ultimate verdict on the application, which is due by May 17.

The company - which took to social media to repeatedly say it stood by the integrity of its data during the committee meeting - has an outcomes study in play but is not expected to have data from that until 2016.

"Recognising the urgent patient need, today we presented what we believe to be a persuasive picture of the evidence for RLX030 so far," commented Tim Wright, global head of development at Novartis Pharmaceuticals.

"The discussion provided important information that we will address with the FDA as it completes its review.  In the meantime we'll continue to drive our robust clinical trial programme and build upon the already established body of evidence," he added.

Serelaxin was also knocked back by the EMA's Committee for Medicinal Products for Human Use (CHMP) earlier this year, although Novartis said it planned to refile the dossier seeking conditional approval on the strength of new data analyses while it waits for the outcomes trial results.

28th March 2014

From: Sales



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