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.
The article Novartis Heart Drug Receives FDA Designation to Expedite Review originally appeared on Fool.com.Fool contributor Tim Brugger has no position in any stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. Try any of our Foolish newsletter services free for 30 days. We Fools may not all hold the same opinions, but we all believe that considering a diverse range of insights makes us better investors. The Motley Fool has a disclosure policy.
Copyright © 1995 - 2013 The Motley Fool, LLC. All rights reserved. The Motley Fool has a disclosure policy.