Hanna Tokkie schreef:
The EMEA declined Pharming’s application to approve Rhucin on the basis of the phase I and II clinical trials and the interim analysis of the double-blind, placebo-controlled phase III clinical trial [825972], [845155], [870700]. The reasons given were the small number of patients treated with Rhucin, which were insuffcient to provide data on its effcacy in life-threatening, particularly laryngeal, attacks; the lack of data on the effects of multiple Rhucin treatments; lack of data on impurities in the Rhucin formulation; and the lack of data on formation of antibodies, particularly to Rhucin or to potential impurities, such as rabbit proteins resulting from the production process, which could be implicated in allergic reactions [861042], [870700]. Pharming intends to request a re-examination to the EMEA and a fnal decision for market authorization will be expected in mid-2008 [872076].