FDAnews Drug Daily Bulletin
Pharmaceuticals / Research and Development

EMA Adopts Revised Drug Development Guidelines for Two Inflammatory Diseases

July 26, 2018

The European Medicines Agency released new guidelines on developing treatments for Crohn’s disease and ulcerative colitis set to take effect Jan. 1.

The recommendations for Crohn’s disease (CD) drugs provide updated advice on considerations for non-generic treatments, including primary and secondary endpoints. The primary endpoint for studies of luminal CD, which causes inflammatory changes in the lumen or tube of the intestine, should be the co-primary evaluation of endoscopic and symptomatic remission, the agency says.

The guidelines discourage using the Crohn’s Disease Activity Index (CDAI) to assess efficacy because of questions about its reliability and validity. Instead, symptoms and inflammation should be evaluated independently as co-primary endpoints.

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