Friday, July 10, 2015

UPDATED: FDA OKs Novartis' megablockbuster heart failure drug Entresto - FierceBiotech

UPDATED: FDA OKs Novartis' megablockbuster heart failure drug Entresto - FierceBiotech

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.

"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."

"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).

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

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