After an FDA rejection and an earlier negative opinion, Novartis' cardio treatment serelaxin has again failed to sway European regulators, and the drugmaker has resigned that its breakthrough-designated therapy will not hit any market this year.
The FDA rejected the heart drug serelaxin, the latest blow to a treatment Novartis hoped would be a cornerstone of a cardiovascular franchise.
The pharma giant announced that the data monitoring committee has hit the green light for any early close to the pivotal study for its new blood pressure treatment LCZ696 after investigators tracked delays in cardiovascular deaths and fewer hospitalizations resulting from heart failure in comparison to Vasotec, a generic blood pressure medicine that has been around for years.
After a daylong session heavy on scathing criticism, a panel of FDA advisers voted unanimously against approving Novartis' in-development heart drug serelaxin, casting serious doubts on the treatment's potential.
One of Novartis's top late-stage drug prospects is in deep trouble. In advance of an upcoming advisory committee meeting, the FDA in-house review says point blank that the application for the heart drug serelaxin should be rejected as the pharma giant has yet to provide the decisive data on efficacy needed to green-light the therapy.
Novartis has nabbed its second breakthrough drug designation from the FDA, raising the prospect that it could shave some time off the regulatory process for the heart drug serelaxin (RLX-030).
With a lead candidate in development for a big cardio market, Cardioxyl Pharmaceuticals has wrapped up a $28.1 million round of equity financing, according to an SEC filing this week. The disclosure follows years of work on a candidate in mid-stage development for acute decompensated heart failure.
And in a preview of its R&D showcase, the pharma giant--which spent an industry-leading $9.58 billion on R&D last year--offered a bullish assessment of a slate of experimental therapies it believes can break past the $1 billion annual revenue mark.
Novartis has detailed the hits and misses from a late-stage trial of its potential blockbuster therapy for acute heart failure, serelaxin, calling the study an overall success and making executives of the Swiss drug giant confident in their plans to seek regulatory approvals. Yet analysts have pointed out that there are some challenges ahead for Novartis to fulfill big expectations for the drug.
Novartis says that a late-stage study of its heart failure drug RLX030 (serelaxin) hit one of two primary endpoints for a key symptom of acute heart failure. Investigators said the drug arm also experienced a lower risk of death compared to the group which received a placebo plus standard of care. The data will be laid out at the AHA meeting in November.