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news.Aspreva Pharmaceuticals and Roche's CellCept has been granted US orphan drug designation for the treatment of pemphigus vulgaris - a rare, severe, chronic autoimmune disease that causes blisters of the skin and mucous membranes.
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Aspreva is currently evaluating CellCept for the treatment of pemphigus vulgaris (PV) in a global phase III study.
The randomized, double-blind, placebo-controlled comparison study is investigating the efficacy and safety of CellCept in 77 patients with active PV over a treatment period of 52 weeks. The primary end point encompasses both minimal disease activity defined as no new persistent lesions, with a low steroid dose. The company expects to complete the study in 2007.
The FDA’s orphan drug designation is intended to encourage the development of new treatments for rare diseases. It is granted for treatments designed to prevent, diagnose or treat rare, life-threatening or chronically debilitating diseases that affect fewer than 200,000 people in the US.