Genentech drug CellCept (mycophenolate mofetil) approved by FDA

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On May 3, 1995, the U.S. Food & Drug Administration (FDA) announced it had approved Genentech’s drug CellCept (mycophenolate mofetil) for the prevention of transplant graft failure. CellCept (mycophenolate mofetil) is an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in adult and pediatric recipients 3 months of age and older of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants.

Its anti-inflammatory and immunomodulatory properties subsequently led to its use in multiple rheumatic diseases. The principal mechanism through which the drug exerts its immunosuppressive effects is by interfering with the purine pathway, upon which activated lymphocytes are dependent. MMF is a pro-drug of mycophenolic acid, which inhibits inosine monophosphate (IMP) leading to decreased B-cell and T-cell proliferation, and decreased antibody production.

MMF has now been the standard of care for lupus nephritis for more than 20 years. Despite its long history and documented effectiveness, particularly in the treatment of lupus nephritis, further studies are warranted to investigate its role in long-term maintenance therapy. The purpose of this study was to describe our 20 years of practice experience using MMF with regard to its indications, safety, tolerability and treatment efficacy. Among patients on long-term treatment, we sought to identify rates of renal flare and progression to end-stage renal disease (ESRD).

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Source: National Library of Medicine
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