Thursday, June 20, 2013

Novartis - USFDA breakthrough designation for Serelaxin, an acute heart failure treatment

USFDA has recognized Novartis acute heart failure drug Serelaxin (RLX030) as a breakthrough. The drug is currently in Phase 3 trials. This is the second breakthrough designation that Novartis has received in the recent past. Recently their NSCLC drug LDK378 was granted breakthrough status.  

The breakthrough designation for RLX030 is based on the Phase 3 study data (RELAX-AHF trial), which showed that patients who received RLX030 had a 37 percent reduction in mortality at 6 months after an acute heart failure episode. 

RLX-030 offers benefits over existing treatment options
None of the approved drugs so far have demonstrated mortality benefit, while RLX-030 has, although the same may be debatable as a play of chance due to smaller size of the trial. Besides morality benefit, RLX-030 has better tolerability including benefits on kidney, which will also support approval prospects.
The last treatment option to be approved for Acute Decompensated Heart Failure was JNJ’s Natrecor (Nesiritide). Natrecor was approved by the USFDA in 2001 based on statistically significant benefit on dyspnea, but failed to demonstrate mortality benefit. Apart from Natrecor other treatment options include Nitroglycerine and Sodium nitroprusside.

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