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    Wednesday, July 8, 2015

    FDA Approves Valsartan/Sacubitril (Entresto) for Heart Failure by 12.5 $ / Tablet

    Novartis Pharmaceuticals’ new heart failure drug Entresto, which is projected to reap $5 billion in sales, earned FDA approval Tuesday – six weeks before the agency's priority review action date when the decision was expected. The drug has been hyped as a “multi-blockbuster” by Novartis Chief Executive Officer Joe Jimenez and hailed as a “mega-brand” by Timothy Anderson, senior analyst at the investment research firm Sanford C. Bernstein, reports FiercePharma.
    Amid the fanfare, Novartis announced the drug’s price and confirmed negotiations are underway for a unique pricing plan intended to put price-sensitive patients and insurers at ease while still earning the company hefty returns.
    Entresto treats patients with heart failure who have low or irregular heartbeats characterized as reduced ejection fraction, which limits their physical activity as defined by the New York Heart Association's standards. This particular form of heart failure affects about 2.2 million Americans, according to the company.
    The new drug reduced patients' risk of death from cardiovascular issues by 20 percent compared with those who were given a generic drug known as enalapril in what David Epstein, division head for Novartis, called the “world’s largest heart failure trial,” featuring 8,442 patients.
    Entresto will be sold at a wholesale price of $12.50 per day, which does not include discounts negotiated between drug companies and private insurers, the federal government and hospitals. Insured patients will likely pay far less, but the full cost for uninsured patients will be about $4,500 per year.

    Item Reviewed: FDA Approves Valsartan/Sacubitril (Entresto) for Heart Failure by 12.5 $ / Tablet Rating: 5 Reviewed By: Unknown

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