Novartis Heart Drug Doesn’t Prove Benefit, FDA Staff Says

Novartis AG’s experimental heart failure medication shouldn’t be approved for sale, U.S. regulators said, potentially dealing a blow to the company’s plan to build a portfolio of cardiac therapies around the drug.

“There is insufficient evidence to support” Novartis’s claim the drug, serelaxin, helps prevent worsening of the disease that causes the heart to malfunction, Food and Drug Administration staff said today in a document posted online. The FDA on March 27 will convene advisers to consider serelaxin.

The therapy failed to win backing from European Union regulators in January who questioned the drug’s benefit. Serelaxin, which is similar to the hormone relaxin that is elevated in pregnant women, is being developed along with another experimental compound for heart failure called LCZ696. Serelaxin could generate $523 million in sales in 2018, based on the average of eight analysts’ estimates compiled by Bloomberg.

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 relied on one clinical trial instead of two that the FDA prefers, and the benefit serelaxin showed may not be meaningful, according to the clinical review prepared by the FDA’s Melanie Blank and Tzu-Yun McDowell. Novartis’s main goal in the trial was to measure serelaxin’s effect on labored breathing even though the company is seeking approval to reduce worsening of heart failure, which the FDA staff called “an exploratory finding” in the study.

Novartis Response

In an e-mailed statement, Novartis said the evidence supporting serelaxin “demonstrates a clinically significant beneficial effect in patients” with heart failure.

The company rose less than 1 percent to close at 72.05 Swiss francs in Zurich.

The FDA is expected to decide whether to approve the drug, which Novartis proposes to call Reasanz, by May 17, according to the document. The reviewers said Novartis should conduct a study to confirm the drug’s benefit on worsening of heart failure as well as its ability to reduce deaths from the condition.

“We do not believe that the data from the trial support the claim that serelaxin reduced the rate of worsening of heart failure,” the FDA staff wrote. Novartis’s definition of worsening heart failure is vague and relied on researchers’ individual judgment, according to the document.

A statistical reviewer at the FDA had similar concerns about the single trial and the significance of the benefit.

Mortality Study

Novartis expects to complete a study on mortality by the end of 2016, said Rob Kowalski, global head of drug regulatory affairs at Novartis.

Novartis eventually wants to gain FDA approval of serelaxin to reduce death from heart failure, Kowalski said. 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.

About 5 million people in the U.S. suffer from heart failure and about 1 million of those are hospitalized each year, Kowalski said. With serelaxin, Novartis plans to target those who end up in the hospital.

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.

Novartis is re-applying for conditional approval from the European Union that will require another review once the trial measuring whether serelaxin reduces deaths is complete.

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