Novartis (NVS - Analyst Report) recently announced that the US Food and Drug Administration (FDA) has granted “Breakthrough Therapy” designation to its pipeline candidate RLX030 (serelaxin) which is being developed to treat patients with acute heart failure (AHF).
The designation, which was enacted as part of the 2012 Food and Drug Administration Safety and Innovation Act, is granted to potential new treatments for serious or life-threatening diseases or conditions where the initial clinical data shows that the treatment has the potential to demonstrate substantial improvement on one or more clinically significant endpoints compared to existing treatments. The designation should help fasten the development and review process for the candidate.
Data from the phase III trial, RELAX-AHF, showed that RLX030 improved symptoms and reduced mortality in patients with acute heart failure (AHF). It was observed that RLX030 reduced dyspnea (shortness of breath) as well as a 37% reduction in mortality at 6 months after an AHF episode as compared to patients undergoing conventional treatment.
We note that RLX030 is currently under regulatory review in several countries including the US and the EU.
We remind investors that Novartis acquired RLX030 through the acquisition of privately-held Corthera Inc. in 2010.
As per Novartis, as many as 3.5 million AHF incidents happen in the US and EU per year with the incidence expected to go up further as the population ages.
We note that Novartis had another candidate LCZ696, which is in phase III development for the treatment of chronic heart failure.
We are encouraged by the pipeline progress at Novartis in recent times. We remind investors that the US FDA granted Breakthrough Therapy designation to lung cancer candidate LDK378 in Mar 2013.
Novartis currently carries a Zacks Rank #3 (Hold). Right now, Novo Nordisk (NVO - Analyst Report) , Salix Pharmaceuticals and Santarus, Inc. look well placed. While Novo Nordisk currently carries a Zacks Rank #2 (Buy), Salix and Santarus carry a Zacks Rank #1 (Strong Buy).