Speedel (Swiss:SPPN.SW - News) today welcomed the announcement that Novartis has received a positive opinion recommending European Union approval of SPP100 (Rasilez[i]) as the first-in-class once daily direct renin inhibitor for the treatment of hypertension. The Committee for Medicinal Products for Human Use (CHMP) issued the positive opinion for Rasilez based on data from more than 7,800 patients in 44 clinical studies which was submitted by Novartis in September 2006. The European Commission generally follows the CHMP’s recommendations and is expected to issue a decision within three months.
