FDA OKs Drug for Heart Transplants
Prograf Already Used in Liver, Kidney Transplants
By Miranda Hitti WebMD Medical News
Reviewed By Louise Chang, MD on Friday, March 31, 2006
March 31, 2006 — The FDA has approved Prograf, a drug that suppresses the body’s immune reaction, to prevent graft rejection in heart transplant recipients.
Prograf capsules and Prograf for injection — the first products approved in the U.S. for heart transplantation in eight years — had been previously approved to prevent graft rejection in liver and kidney transplant recipients.
“This approval is another example of the benefits of our agency’s ‘orphan’ drugs program, which seeks to answer the medical needs of small groups of patients,” says the FDA’s Steven Galson, MD, MPH, in a news release. Galson directs the FDA’s Center for Drug Evaluation and Research.
“The doctors who perform approximately 2,200 heart transplants in the U.S. each year will now have a new option for enhancing successful outcomes by preventing the rejection of the grafted organs,” Galson says.
もともと腎・肝移植のグラフト(移植片)拒絶反応予防に使われていた薬がカプセル状だけでなく注射でも承認された、と。真ん中パラグラフに出てくるorphan drugとは、検索してみると
オーファンドラッグ(Orphan drug)とは、極めて希な疾病の治療に用いられる薬品のこと です。
だそうです。リスクとしては神経毒、感染症、腎機能障害、移植後の糖尿病発症など。
最近なぜかうちでも多い移植の話について、「5号館のつぶやき」さんが発生学の視点から興味深い「臓器移植というパンドラの箱」というエントリを書いていらっしゃるのでTBします。