Pharma Focus Asia

FDA approves Pfizer drug, Rapamune to treat very rare lung disease lymphangioleiomyomatosis

Friday, May 29, 2015

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.

 

reuters.com

magazine-slider-imageMFA + MMA 2024CPHI Chine || PMEC China 2024Asia Healthcare Week 2024Advance DoE WorkshopNitrosamine Advance Workshop 2024CPHI Korea 2024CHEMICAL INDONESIA 2024INALAB 2024 Thermo Scientific - DynaDrive and DynaSpinDigital Health Asia 2024Rehab Expo 2024ISPE Singapore Affiliate Conference & Exhibition 20242024 PDA Pharmaceutical Manufacturing & Quality Conference2024 PDA Cell and Gene Pharmaceutical Products Conference 2024 PDA Aseptic Manufacturing Excellence Conference2024 PDA Aseptic Processing of Biopharmaceuticals Conference3rd World ADC Asia 2024LogiPharma Asia 2024