Novartis Heart Drug Receives FDA Designation to Expedite Review

The Food and Drug Administration has granted Switzerland-based Novartis its "Breakthrough Therapy" (BT) designation for Novartis' acute heart failure (AHF) treatment RLX030 (serelaxin), the company announced today.

According to the FDA, a BT designation is intended to "expedite the development and review of drugs for serious or life-threatening conditions."

The decision came after reviewing evidence including the results of Novartis' Phase 3 RELAX-AHF trial in which there was a 37% reduction in mortality for patients using RLX030 for six months compared to traditional treatments. According to Novartis, RLX030 has the potential to be "the first breakthrough treatment for acute heart failure patients in 20 years."

In response to the FDA's decision, Division Head of Novartis Pharmaceuticals David Epstein was quoted as saying, "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."

RLX030 is the second Novartis treatment to receive the BT designation following LDK 378, a lung cancer medication that was fast-tracked by the FDA.


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