Novartis has been granted a priority review for its new heart failure drug LCZ696, setting up a possible approval for the blockbuster-in-waiting in August.
The shortened review time comes on the back of clinical data showing that LCZ696 can dramatically reduce death and hospitalisation rates when added to standard therapy for heart failure, prompting Novartis’ pharma chief David Epstein to describe the drug as “possibly the most exciting launch the company has ever had.”
Analysts have become progressively more enthusiastic about the drug’s prospects in light of the new data, with a number now predicting sales of $5bn or more within four years of its launch in heart failure with reduced ejection fraction (HFrEF), and potentially more if trials support its use in other HF variants, such as patients with preserved ejection fraction.
Last November, LCZ696 also become the first cardiovascular drug to be entered into the EU’s little-used accelerated review process, slashing its review time from 210 to 150 days and setting it on course for a possible approval before the end of the year. It has also been granted a priority review in Switzerland.
LCZ696 is a follow-up to Novartis’ big-selling angiotensin II receptor antagonist Diovan (valsartan) – combining the AIIRA with novel neprilysin inhibitor sacubitril – and is thought to work by reducing the strain on the failing heart.
It enhances the protective neurohormonal systems of the heart while simultaneously suppressing the harmful renin-angiotensin-aldosterone system (RAAS), which is addressed by current heart failure treatment such as ACE inhibitors and AIIRAs.
“The FDA’s decision reflects the significant need to extend and improve life for HFrEF patients,” said Epstein. “Novartis is working to ensure LCZ696 can become available in the US as soon as possible.”
In addition to its impressive clinical data, Novartis also has a significant lead in the marketplace, with no another AIIRA/neprilysin inhibitor combinations currently advancing through clinical development.
Novartis notes that nearly six million people live with heart failure in the US, and despite current therapies, up to 50% of patients die within five years of diagnosis.