Breakthrough in action

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...