First Approval For Roche's Mycophenolate Mofetil

Roche has received marketing clearance from the US Food and Drug Administration for CellCept (mycophenolate mofetil) for the prevention of acute kidney transplant rejection. Discovered and developed by its new subsidiary Syntex, CellCept is indicated for administration with ciclosporin and corticosteroids for the prevention of acute rejection episodes in these patients.

The approval follows sharply on from a positive recommendation from an FDA advisory panel that CellCept should be approved (Marketletter April 10). Syntex submitted the application in November 1994. Acute rejection occurs in about 30%-50% of kidney transplant patients, most frequently in the first three months post-transplantation. It is a particular problem in pediatric patients.

Syntex' New Drug Application 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.