FDA Rejects Approval of Novartis drug Serelaxin for Heart Failure

FDA Rejects Approval of Novartis drug Serelaxin for Heart Failure

The U. S. Food and Drug Administration (FDA) panel have voted against the Novartis AG experimental heart failure drug, Serelaxin. The agency said that the company has given insufficient evidence in support of the proposed indication and moreover reviewers have also not released safety concerns about the drug.

The agency added that the drug was successful in fulfilling only one of its two primary endpoints and failed to slow down the progress of heart failure. According to sources, the rejection of the drug for sale in market is second set back for the pharmaceutical major Novartis in 2014.

Earlier, European regulators also rejected approval for marketing the drug in late January. But, now the company has to submit revised filing package of the drug for examination to the European Medicines Agency for conditional marketing approval of Serelaxin.

More than 15 million people across the world fall victim to heart failure every year. As per average of eight analysts estimates compiled by Bloomberg, Serelaxin could generate $523 million in sales in 2018.

Analysts estimated that the development of the Serelaxin could even challenge two drugs, Diovan and Gleevec, by Basel, Switzerland-based drug maker. The two drugs generated revenue of about $8.2 billion of Novartis's $58 billion in 2013.

A meeting will be conducted by the FDA's Cardiovascular and Renal Drugs Advisory Committee to discuss and vote on the biologics license application (BLA), for Serelaxin injection. In June 2013, the Serelaxin drug, a recombinant human protein identical to naturally occurring peptide hormone relaxin in pregnant women, was granted a Breakthrough Therapy designation status.

FDA said that it does not believe on single trial success of the drug and will decide whether to approve the serelaxin drug by May 17.


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