Rhucin BLA submission expected in 2012 as Phase III trial agreed
This article was originally published in Scrip
Executive Summary
Pharming and Santarus have now reached agreement with the US FDA on the design of a Phase III trial of Rhucin (recombinant human C1 inhibitor), which will support a Biologics License Application (BLA) submission under the Special Protocol Assessment (SPA) process. "The study is still expected to be completed by the third quarter of 2012," the companies said.
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