Novartis officials were hoping the FDA would give approval for what they hope will be a blockbuster drug for heart failure by the end of the summer. On Tuesday, they got even better news.The U.S. Food & Drug Administration approved Entresto (formerly called LCZ696) six weeks ahead of the priority review action date.
David Epstein, a division head for the pharma giant, which has its U.S. headquarters in East Hanover, said the drug can have life-saving and life-prolonging benefits for millions with heart failure — and that the company will now rush to get the product to market.
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“Millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital,” he said in a release from the company’s international headquarters in Basel, Switzerland.
“We recognize our responsibility to ensure Entresto reaches U.S. patients and prescribers as soon as possible and will begin shipping in the U.S. in the coming week.”
The drug could be a huge financial windfall for the company.
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Novartis President and U.S. Country Head Christi Shaw, speaking at a media gathering last month, said the drug has the potential to bring $3 billion to $5 billion in revenue.
“We expect it to be the largest contribution to Novartis AG overall globally and the largest in Novartis US, because there are 6 million patients living with heart failure,” she said in June.
The drug will be used in treatment of heart failure with reduced ejection fraction, the company said in its release. Entresto, the release said, will be available on prescription for patients whose condition is classified NYHA class II-IV, indicated to reduce the risk of cardiovascular death and heart failure hospitalization.
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