The U.S. Food and Drug Administration (FDA) has rejected the Novartis (NVS) drug RLX030 (serelaxin).
The company was seeking approval for the acute heart failure drug but the agency rejected it. The FDA said that it needs more evidence to support how effective the Novartis drug is before passing approval on it.
The pharmaceutical has responded by expediting a second phase III study to prove how effective the drug really is. “We are disappointed by the setback of RLX030. We expect investor focus to remain on further updates on revised filing in the U.S. and EU,” Novartis said.
NVS stock was down on Friday.