Novartis AG's Potential Blockbuster Heart Drug Could Get FDA Approval by Summer

Novartis AG (NVS)'s Potential Blockbuster Heart Drug Could Get FDA Approval by Summer
February 16, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff

Novartis AG announced on Friday that the U.S. Food and Drug Administration (FDA) has granted priority review for LCZ696, its drug for the treatment of heart failure with reduced ejection fraction (HFrEF).

The target date for the FDA to issue its evaluation of LCZ696 is now in August 2015. The priority review designation has reduced the review process of the drug from 12 to eight months.

“The FDA's decision to grant priority review brings us one step closer to making this promising treatment available to the millions of Americans who are struggling with this debilitating condition,” said Christi Shaw, U.S. country head and president of Novartis Corporation, in a statement. “LCZ696 has the potential to change the way that many heart failure patients are treated in this country, giving them and their loved ones greater hope for their future.”

Novartis’ New Drug Application (NDA) for LCZ696 is based on results from its clinical trial, named PARADIGM-HF, which showed that the drug reduced the risk of either cardiovascular death or heart failure hospitalization by 20 percent as compared to the guideline therapy ACE-inhibitor enalapril. The results were published in The New England Journal of Medicine in September 2014.

“The trial was stopped early, according to prespecified rules, after a median follow-up of 27 months, because the boundary for an overwhelming benefit with LCZ696 had been crossed,” the investigators stated in the results section of the paper.

Analysts are predicting that sales of the drug could reach $5 billion within four years of the drug’s launch, according to PMLIVE, the website associated with the monthly print magazine Pharmaceutical Market Europe (PME). These predictions are based not only on LCZ696’s successful clinical trials but also on the drug’s uniqueness in the market. LCZ696 is the only AIIRA/neprilysin inhibitor combination currently in clinical development.

The importance of LCZ696 in the chronic heart failure treatment (CHF) field cannot be overestimated. Decision Resources Group, which provides the pharmaceutical, biotech and financial services industries with key market analytics, issued an assessment of the drug in October 2014.

“LCZ-696 [sic] has demonstrated the potential to disrupt the well-established CHF treatment algorithm following favorable results from the PARADIGM-HF study. This exciting new agent represents a step up from past and present agents in development for CHF in that it could replace the standard of care for many CHF patients,” analyst Joseph Dwyer commented at the time.

Based on the LCZ696’s potential to revolutionize the CHF market, Decision Resources Group predicted that the “CHF market will grow from approximately $2.9 billion in 2013 to $8.9 billion in 2023.”



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