FDA's breakthrough pathway seems to be working as designed, despite an advisory committee vote against Novartis AG's serelaxin in acute heart failure, an indication where no approved drugs have a mortality benefit.

On March 27, FDA's Cardiovascular and Renal Drugs Advisory Committee voted 11-0 against approval of the recombinant protein to improve the signs and symptoms of AHF through a reduction in the rate of worsening of heart failure.