Santarus and Pharming Announce Special Protocol Assessment Agreement with FDA for RHUCIN Phase III Clinical Study

Santarus, Inc. SNTS and biotech company Pharming Group NV earlier today announced that they have reached agreement with the U.S. Food and Drug Administration on the design of a Phase III clinical study with the investigational drug RHUCIN® (recombinant human C1 inhibitor) under the Special Protocol Assessment process that is intended to support the submission of a Biologics License Application.