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news.Roche's lead immunosuppressant drug CellCept for myasthenia gravis was deemed to fail both primary and secondary goals after a preliminary review of data from a phase III trial.
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In July 2003, Aspreva signed a collaboration agreement with Roche for the exclusive worldwide rights to develop and, upon regulatory approval, commercialize CellCept for all autoimmune disease applications.
The clinical trial was designed to evaluate the efficacy and safety of CellCept in maintaining or improving symptom control in patients with myasthenia gravis over a treatment period of 36 weeks. The primary endpoints in the trial included minimal disease activity while maintaining a designated low steroid and cholinesterase inhibitor doses.
Analysis showed that CellCept appeared to be generally well tolerated by the patients in the study. The most frequent adverse events were diarrhea, muscle spasms and other symptoms related to the disease.