FDA approves Astellas drug for preventing kidney rejection

Drug approved for use with CellCept, corticosteroids, Simulect

NORTHBROOK, Ill. — The Food and Drug Administration has approved a drug made by Japanese drug maker Astellas for preventing the body from rejecting transplanted organs, the company said.

Astellas announced through a U.S. subsidiary that the FDA had approved Astagraf XLTM (tacrolimus) extended-release capsules for preventing rejection of transplanted kidneys, for use with Genentech's CellCept (mycophenolate mofetil) and corticosteroids, with or without Simulect (basiliximab), a biotech drug made by Swiss drug maker Novartis.

"Each transplant recipient is different and requires a personalized treatment approach," Astellas Pharma chief medical officer Sef Kurstjens said. "Astellas is pleased to continue our more than 20-year commitment to the field of transplant immunology."


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