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Novartis Rasilez NDA in early ‘06

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Novartis is on track to submit its oral renin inhibitor Rasilez (aliskiren, formerly SPP100) in early 2006 and in the EU in the fourth quarter, the firm says Jan. 19. The submissions will pursue both monotherapy and combination treatment based on Novartis' 8,000-patient program. Also on Jan. 19, the company reported Phase III data "reconfirming SPP100 as a potential gold standard." Building on co-administration data released in 2005, the firm disclosed key results from Phase III studies looking at monotherapy and co-administration with amlodipine and ramipril. The three studies showed "strong monotherapy efficacy at least as good as or better than other classes of hypertensive therapies" and "superior blood pressure lowering" in combination with any of the four main antihypertensive classes. The company has pointed to aliskiren's potential to be used as both monotherapy and combination therapy and to the agent's improved end-organ protection as advantages (1Pharmaceutical Approvals Monthly February 2005, p. 3)...

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