BioCentury
ARTICLE | Product Development

Betting big on hearts

How Novartis built clinical case to replace generics in heart failure

September 8, 2014 7:00 AM UTC

Though saturation by cheap generics and a high-profile failure of another compound led some companies to exit the heart failure space, results from the PARADIGM-HF trial suggest Novartis AG made the right call by doubling down in its Phase III program for LCZ696. The key was the pharma's decision to design a robust trial that would show outcomes relevant to multiple stakeholders, with the goal of thoroughly supplanting angiotensin-converting enzyme inhibitors in the indication.

The study design is a model for how companies can provide robust data - even against generics - in the brave new world in which regulators, payers, physicians and patients all have different data requirements...