Heart failure medication falls short of primary endpoint in phase 3 trial
Novartis announced that a phase 3 study evaluating the company’s investigational heart failure medication (serelaxin) did not meet its primary endpoint.
Results of the RELAX-AHF-2 study found that patients with acute heart failure who received serelaxin did not have a reduction in cardiovascular death through 180 days or a reduction in worsening heart failure through five days when added to standard therapy, according to a news release.
In May 2014, the FDA refused to approve serelaxin, 11 months after the agency granted the infusion medication a breakthrough therapy designation.
“We are disappointed this study did not confirm the efficacy of [serelaxin] in acute heart failure, especially given the urgent need for effective new treatments for this condition,” Novartis chief medical officer Vas Narasimhan said in a news release. “We will continue to further analyze the data to better understand and learn from these results as well as evaluate next steps for the overall program.”
Novartis’s heart failure portfolio includes sacubitril/valsartan (Entresto), a twice-daily oral medication that the FDA approved in July 2015. After sales of the drug failed to meet expectations, Novartis announced last July that it would spend an additional $200 million before the end of the year to promote sacubitril/valsartan.
In 2016, the company had $170 million in sacubitril/valsartan sales, including $68 million during the fourth quarter. Last May, the American College of Cardiology, American Heart Association and Heart Failure Society of America released guidelines that gave a class I recommendation to sacubitril/valsartan.
Novartis said in its 2016 annual report that it expects to triple the prescription volume for sacubitril/valsartan in the U.S. by the fourth quarter of 2017.
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.