Novartis heart failure drug gets FDA incentives
Novartis says acute heart failure drug serelaxin gets breakthrough incentives from FDA
NEW YORK (AP) -- Novartis AG said Friday its drug serelaxin, a treatment for acute heart failure, received breakthrough therapy status from the Food and Drug Administration.
The drug is intended to treat symptoms of acute heart failure episodes. Novartis said there are about 3.5 million of those in the U.S. and European Union every year.
Novartis said patients treated with serelaxin in a late-stage trial were 37 percent less likely to die in the six months after a heart failure episode compared with patients who received standard treatment.
The FDA created the breakthrough therapy program in 2012 as a way to speed up the approval process for drugs that could be significant improvements in the treatment of serious or life-threatening diseases from what's currently on the market.
Shares of Novartis rose 8 cents to $70.09 in morning trading.
