Novartis Fails to Win U.S. Approval for Serelaxin Heart Drug

Novartis AG’s heart-failure medication failed to win U.S. approval, setting back the company’s plan to build a portfolio of cardiac therapies around the drug.

The Food and Drug Administration asked for more information about the medicine called serelaxin, according to a statement from the company. A panel of advisers to the FDA unanimously recommended against approval March 27. They agreed with FDA staff members who said in a March 25 report they found insufficient evidence that serelaxin will benefit patients. Novartis said it will expedite a program of clinical trials to gather more evidence.

The drug, similar to the hormone relaxin that protects the hearts of pregnant women, failed to win backing from European Union regulators who questioned the drug’s efficacy in January. The Basel, Switzerland-based drugmaker needs to make up for anticipated revenue losses as the heart medicine Diovan and cancer treatment Gleevec, its biggest sellers, start to face generic competition. The two made up about $8.2 billion of Novartis’s $58 billion in 2013 revenue.

Novartis has “been encouraged by feedback from FDA advisory committee members noting the data are intriguing,” Tim Wright, Novartis’s head of development, said in the statement. He said the company continues to believe serelaxin “has the potential to be an important treatment.”

Blood Pumping

Heart failure occurs when the heart can’t pump enough blood to the body. Doctors have relied on nitrates and diuretics to relax the heart’s blood vessels and reduce fluid build-up. Serelaxin was tested in addition to the standard of care.

About 5 million people in the U.S. suffer from heart failure and about 1 million of those are hospitalized each year, Rob Kowalski, global head of regulatory affairs at Novartis, said before the advisory panel meeting. With serelaxin, Novartis plans to target those who end up in the hospital.

Novartis sought approval for serelaxin to prevent heart failure from getting worse based on a study that primarily measured the drug’s effect on labored breathing.

The company eventually wants to gain FDA approval of serelaxin to reduce death from heart failure. The FDA granted serelaxin breakthrough status for the use, meaning the agency considers it a likely substantial improvement over current therapies and will expedite review of the drug.

Novartis expects to complete a study on mortality by the end of 2016, Kowalski said.

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