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FDA Grants Breakthrough Status to Heart Failure Drug



The pharmaceutical company Novartis, based in Switzerland, says the U.S. Food and Drug Administration designated its drug candidate RLX030 (serelaxin) a breakthrough therapy for the treatment of acute heart failure. Serelaxin is an engineered form of the natural hormone human relaxin-2 proposed for use in emergency rooms.

FDA assigns breakthrough status to expedite drugs in development to treat serious or life threatening conditions. To receive the designation, drug candidates need to show clinical evidence that the compound can make a substantial improvement in at least one therapeutic feature over current treatments. Candidates receiving the designation get fast-track consideration, as well as senior-level involvement in its review by the agency.

Novartis says FDA’s decision was based on results of a late-stage (phase 2-3) clinical trial that tested serelaxin against a placebo with 1,161 patients admitted to hospitals in the U.S. and Israel with acute heart failure. Patients receiving the drug had a 37 percent reduction in mortality after six months following an episode of acute heart failure, compared to those receiving conventional treatments alone. The trial reported that serelaxin treatments were well tolerated and safe to patients, comparable to conventional therapies.

Human relaxin-2 is a naturally occuring hormone present in men and women. Among pregnant women, however, its levels rise to meet additional cardiovascular demands of pregnancy. Serelaxin is designed to be administered to patients admitted to emergency rooms for acute heart failure episodes over a 48 hour period, along with conventional therapies.

Heart failure occurs when the heart cannot pump blood to support other organs in the body, depriving the body of needed oxygen. The Centers for Disease Control and Prevention says some 5.7 million people in the U.S. have heart failure, causing more than 55,000 deaths per year. Novartis cites its own data showing 3.5 million episodes of acute heart failure each year in the U.S. and Europe.

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Hat tip: FirstWord Pharma

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