Tags: Heart Disease | heart failure drug | FDA | pregnancy hormone | Novartis AG | Serelaxin | breakthrough status

Promising Heart Failure Drug Fast-Tracked for Approval

Friday, 21 Jun 2013 08:01 AM

Novartis AG won “breakthrough”status from U.S. regulators for an experimental drug to treat acute heart failure, raising the prospect of faster approval.
Serelaxin, a man-made version of a hormone found in pregnant women, reduced death rates by 37 percent in patients with acute heart failure six months after treatment, according to clinical trial results presented last year.
Also known as RLX030, The drug is Basel, Switzerland-based Novartis’s second to receive the new designation from the U.S. Food and Drug Administration after the lung-cancer treatment LDK378. Faster approvals of the two drugs would provide a sales boost for Novartis, Europe’s biggest drugmaker, just as the company’s best-selling products are losing patent protection.
“Commonly used medicines for AHF only improve the immediate symptoms, so the additional effect on survival observed with RLX030 offers hope to patients and physicians,” David Epstein, division head of Novartis Pharmaceuticals, said in a statement Friday.
Novartis’s Diovan hypertension drug started to lose patent protection last year. Gleevec, a cancer treatment, will be open to copies starting in 2015. Together, they generated $9.1 billion in sales last year. The company has filed for approval of Serelaxin in the U.S. and the European Union.
Other therapies that have received the breakthrough designation since it was established last year include Pfizer’s breast-cancer drug palbociclib and Johnson & Johnson and Pharmacyclics Inc.’s ibrutinib for certain types of blood cancer. Xalkori was approved in 2011, before the FDA program was introduced.
Acute heart failure often occurs in the wake of other ailments such as hypertension, diabetes or coronary artery disease and may strike about one in 10 people over the age of 65. Doctors now use a mix of drugs and devices to help patients feel better, yet half of those hospitalized don’t survive longer than five years. RLX030 is a manufactured copy of relaxin-2, a hormone whose levels rise during pregnancy.

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