July 8, 2013- The FDA granted Novartis the coveted “Breakthrough” status for drug serelaxin to treat acute heart failure. If approved, it will be the first drug in decades to address AHF. Also, early data suggest that serelaxin might have a survival benefit, which would be unprecedented.
To learn more, we interviewed Gregg Fonarow, MD, Director, Ahmanson-UCLA Cardiomyopathy Center and Co-Chief of Clinical Cardiology. He discusses the strengths and weaknesses of the Phase 3 trial upon which the FDA based the decision to grant Breakthrough status.