Aspreva Pharmaceuticals and Roche today announced that the FDA has granted orphan drug designation for CellCept (mycophenolate mofetil) in the treatment of pemphigus vulgaris (PV). Aspreva is currently evaluating CellCept for the treatment of 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.