Novartis announced that it received a Complete Response Letter from the FDA indicating that the agency will not approve a Biologics License Application for serelaxin for the improvement of acute HF symptoms via reduction of the rate of worsening of HF.
Novartis said it still believed the drug has the potential to become an important treatment for acute heart failure and was “encouraged by feedback from FDA advisory committee members noting the data are intriguing,” said Tim Wright, Novartis’ global head of development.
“In accordance with the FDA’s advice we will continue to expedite our clinical trial program to build the supporting body of evidence,” he added.
Novartis is seeking approval of the drug, which it hopes to market under the brand name Reasanz, for acute heart failure, in which patients can experience fluid buildup, coughing and choking. Heart failure means the heart has weakened pumping ability for reasons including coronary artery disease and damage from a virus.
Novartis has seen the drug as having enormous potential, in large part because drugs for acute heart failure have been so unsuccessful.