Boston, MA 05/19/2014 (wallstreetpr) – Switzerland-based drug giant Novartis AG (ADR) (NYSE:NVS) suffered a rejection in the hands of the U.S. Food and Drug Administration (FDA) that declined to approved its much-touted heart failure medication, serelaxin or RLX030.
However, the company said it will push forward with efforts to bring the drug to the market as soon as possible. As such, the company intends to build a fresh body of evidence to back the efficacy of the drug. The FDA rejected the drug on the basis of insufficient efficacy evidence, following in the footsteps of its advisory committee that in March unanimously recommended rejection of RLX030.
The company plans to enlist 6,300 patients for the second phase of evidence collection under its second late-stage trial. The company looks to its heart failure drug candidate as a potential redeemer given that it faces hard times ahead as its bestselling drugs lose their patent protection.
The company seeks to make up for Gleevec and Diovan, two of its biggest sellers that lost their market exclusivity and face competition from generic versions. The two drugs contributed about $8.2 billion of the $58 billion that Novartis AG (ADR) (NYSE:NVS) generated in revenue in 2013.
Market potential
Novartis’ experimental heart failure drug has a huge market potential. In addition to a bigger population of people living with heart conditions in the U.S., the company also intends to build a portfolio of heart therapies around the drug.
According to Novartis, about 5 million people in the U.S. have chronic heart failure conditions while about 1 million are hospitalized in relation to acute heart failure conditions. The company revealed that about 22 percent of the hospitalized patients with acute heart failure end up losing their lives within a year. As such, the company not only seeks to support its revenue growth, but also bring hope to heart failure patients in the U.S. and around the world.
Encouraging feedback
Although FDA rejected serelaxin, FDA advisory committee that recommended the rejection of the drug noted that the data provided by the company were intriguing. Novartis AG (ADR) (NYSE:NVS) seeks to build on the encouraging feedback to bring new evidence on the drug.
