WASHINGTON, May 28 (Reuters) - The U.S. Food and Drug Administration on Thursday approved the first drug to treat a rare, progressive lung disease that mainly affects women of childbearing age.
The drug, Rapamune, known chemically as sirolimus, is made by Pfizer Inc and is designed to treat lymphangioleiomyomatosis (LAM), a disease that causes lung damage and affects only two to five women per million worldwide.
The drug was originally approved in 1999 to help prevent organ rejection in patients receiving kidney transplants. It was reviewed under the FDA’s “breakthrough therapy” program, which helps speed products for unmet needs through the development and regulatory process. (Reporting by Toni Clarke; Editing by Sandra Maler)