UPDATED: FDA OKs Novartis' megablockbuster heart failure drug Entresto

Novartis CEO Joe Jimenez

The FDA has approved Novartis' ($NVS) big 2015 blockbuster, the heart failure drug Entresto, better known in development circles as LCZ696.

Novartis wowed regulators with data demonstrating that the drug reduced the rate of cardiovascular death and hospitalizations among thousands of patients with a particular form of heart failure in a late-stage study, successfully treating a condition that afflicts some 5 million-plus Americans. And the agency responded with an approval that arrived 6 weeks ahead of their scheduled deadline.

Now the Swiss giant will be expected to roll out a creative pricing plan that will be closely watched by the industry. Novartis pharma chief David Epstein has said that the company plans to offer the drug at a discount, looking for bonus payments based on the drug's ability to cut down on the cost of hospitalizations.

"The U.S. wholesale acquisition cost will be $12.50 a day ($4,562 a year), less discounts," a spokesperson for Novartis tells FierceBiotech. "This is in line with the current price of other new CV therapies and well below other recently launched life-saving products for other diseases. The cost to patients will vary as this is ultimately set at the retail level and many factors contribute to an individual's out-of-pocket costs."

Novartis CEO Joe Jimenez has enthusiastically called this one a "multi-blockbuster," and the company's statement on the approval estimates peak sales at $5 billion. Some analysts have pushed their peak projections as high as $10 billion, which would make it one of the most profitable therapies in the world. But Jimenez has cautioned against such sky-high projections as overenthusiastic.

"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," noted Epstein, who has tapped this drug launch as one of the most exciting new entries in years.

Analysts have been equally pumped about the huge marketing potential of this drug.

"The company sits in front of a new product launch that is likely to become a mega-brand over time (Entresto, aka LCZ696 for heart failure) yet the initial uptake is likely to be on the slower side given the entrenched nature of off-patent ACE inhibitors (discounted into expectations)," Bernstein's Tim Anderson recently noted. "It is highly unusual that there are no other major competitors with their own heart failure pipeline drugs in development, providing a long runway."

LCZ696's stellar data and a breakthrough reputation on both sides of the Atlantic helped chill expectations for Amgen's ($AMGN) newly approved heart treatment Corlanor (ivabradine). Even some concerns about a potential link to Alzheimer's--recently outlined by French researchers--have barely shaken the faith for LCZ696.

"The very meaningful survival advantage of Entresto seen in the PARADIGM-HF trial should persuade physicians to consider Entresto for all appropriate patients, in place of traditional ACE inhibitors or angiotensin receptor blockers," said Dr. Milton Packer, chair for the Department of Clinical Sciences at University of Texas Southwestern Medical Center. "Entresto is expected to change the management of patients with HFrEF for years to come."

The most common side effects seen in participants being treated with Entresto were low blood pressure (hypotension), high blood potassium levels (hyperkalemia), and poor function of the kidneys (renal impairment).

"Heart failure is a leading cause of death and disability in adults," said Dr. Norman Stockbridge, director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research. "Treatment can help people with heart failure live longer and enjoy more active lives." 

- here's the release from the FDA
- here's the release from Novartis

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