CellCept Launched In 1st Market

Roche Laboratories has launched its immunosuppressant drug CellCept (mycophenolate mofetil) in its first market, the USA, for the prevention of acute kidney transplant rejection. It is the first novel transplant drug to be launched in that country since ciclosporin A was introduced there by Sandoz in 1983. The drug was originally developed by Roche subsidiary Syntex, and the New Drug Application was approved in May.

Syntex' NDA was supported by data from three double-blind controlled clinical trials, each involving around 500 newly- transplanted recipients. Efficacy was determined by comparing mycophenolate mofetil with Wellcome's Imuran (azathioprine; one trial) or placebo (two trials) in patients receiving standard immunosuppressive therapy (ciclosporin and corticosteroids), on the incidence of first acute rejection episodes or treatment failures six months after transplantation.

At a dose of 2g/day, CellCept was associated with acute rejection rates of 14%, 17% and 18% in the three trials, compared to 40%, 32% and 29% respectively in the control groups.