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FDA approves Rapamune for rare lung disease

May 30, 2015 12:56 AM UTC

FDA approved Rapamune sirolimus from Pfizer Inc. (NYSE:PFE) to treat lymphangioleiomyomatosis (LAM), a rare, progressive, cystic lung disease in women. Rapamune is the first approved drug in the indication; it has Orphan Drug and breakthrough therapy status and received Priority Review.

The agency based its approval on the 89-patient Phase III MILES trial, in which patients receiving Rapamune had significantly slower decreases in forced expiratory volume at one second (FEV1) vs. placebo over a 12-month period. ...