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Expert opinion on investigational drugs

Ciclosporin aerosol in lung transplantation.


PMID 16859398

Abstract

The development of ciclosporin as an aerosol for rejection immunosuppression following lung transplantation started as a research idea at the University of Pittsburgh in 1989. In the 17 subsequent years, the development of the aerosol, testing in animals and several protocols testing the drug in patients have all taken place at the University of Pittsburgh and State University of New York. No other medical advances have displaced the potential of the drug during this time in lung transplantation, which still has a dismal 5-year survival of 50%. Therefore, the recent publication of the double-blind, placebo-controlled study of aerosolised ciclosporin for long-term use to significantly improve patient survival was heralded as a breakthrough by the commentary in the New England Journal of Medicine. Nevertheless, multiple problems may prevent this drug from ever receiving FDA approval and reaching the market. These problems include the need for a multi-centre study, a lack of surrogate markers for chronic rejection in lung transplant patients and a drug formulation that will prevent the expansion of the use of aerosolised ciclosporin for other indications.