FDA reviewers rebuff serelaxin in briefing documents

FDA reviewers recommended against approval of Reasanz serelaxin ( RLX030) from Novartis AG (NYSE:NVS; SIX:NOVN) because of "insufficient evidence to support the proposed indication" of improving the symptoms of acute heart failure (AHF) through reduction of the rate of heart failure worsening. In briefing relaxin 2 ( RLN2; H2). Reasanz has FDA breakthrough therapy designation for AHF. ...