Novartis' serelaxin gains FDA breakthrough status for acute heart failure

Novartis announced Friday that the FDA granted breakthrough therapy status to serelaxin, also known as RLX030, for the treatment of patients with acute heart failure (AHF). The company noted that regulatory filings for serelaxin are currently being reviewed by health authorities including in the US and Europe for the treatment of AHF.

The drugmaker indicated that the FDA's decision was supported by data from the Phase III RELAX-AHF trial, which showed that patients who received serelaxin had a 37 percent reduction in mortality at 6 months after an AHF episode compared to conventional treatment. David Epstein, head of Novartis' drug unit, remarked that "commonly used medicines for AHF only improve the immediate symptoms, so the additional effect on survival observed with [serelaxin] offers hope to patients and physicians."

Last year, Novartis highlighted serelaxin as one of 14 drugs that it expects to generate sales of more than $1 billion by 2017. Deutsche Bank analysts estimate that if approved, serelaxin could generate annual revenue of $2.5 billion. The therapy is a form of the naturally occurring hormone relaxin-2, levels of which rise in pregnant women.

To read more Top Story articles, click here.