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.
