No Approval for Novartis’s Breakthrough Heart Drug


Novartis AG (NYSE:NVS) was denied approval for serelaxin, a drug developed to treat acute heart failure, by the European Medicines Agency on Friday, reports the Wall Street Journal. Novartis’ bad news comes just as GlaxoSmithKline announced in a press release that it won a recommendation for approval for its type-2 diabetes drug Eperzan (albiglutide) from the same agency.

Serelaxin, which is being branded as Reasanz, was developed as part of an effort to replenish the company’s product range as a new wave of generic competitors encroach on some of the company’s top-selling products. Novartis has said that it will ask the EMA to re-examine the drug, and will submit a “revised filing package” to support the drug’s application for approval. The company hopes that serelaxin will gain conditional approval from the regulator upon re-examination. If granted, conditional approval would allow Novartis to market the drug in Europe while continuing late-stage trials of the medicine, according to the Wall Street Journal.

The Committee for Medicinal Products for Human Use (or, CHMP), cited in particular their analysis of the RELAX-AHF trial that was published in 2012. In its explanation of the decision not to approve serelaxin, the CHMP wrote, “further studies would be needed to confirm the effectiveness of Reasanz in the treatment of acute heart failure,” per Forbes.

Novartis’ Chief Executive Officer David Epstein said that serelaxin has the potential to become a blockbuster drug, a term which means the medicine could generate at least $1 billion in revenue a year, per the Wall Street Journal.

Acute heart failure is a widespread condition in which the heart is unable to pump enough blood. Currently, there are no specific treatments currently available for patients with the condition. Novartis’ serelaxin is a form of human hormone that works to treat heart failure by relaxing the blood vessels, allowing the heart to pump more blood. More than 15 million people suffer from acute heart failure globally, according to a Novartis press release, and the condition is often fatal; currently 20-30 percent of patients die within a year of first experiencing an acute heart failure episode.

Novartis is currently carrying out a phase 3 trial of the drug and the medicine is also currently under review in the U.S., where it was awarded “breakthrough therapy” status by the FDA in June of 2013.