Aspreva and Roche's CellCept gains orphan status
Canadian drugmaker Aspreva and Swiss pharmaceutical major Roche say that the US Food and Drug Administration has granted Orphan Drug designation to CellCept (mycophenolate mofetil), for the treatment of myathenia gravis.
The drug, which is being jointly developed by the two firms, is currently being assessed in a randomized, double-blind, placebo-controlled global Phase II study designed to establish its safety and efficacy over a period of 36 weeks. The primary endpoints of the trial are minimal disease activity and low steroid dose, with the results expected in late 2006.
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