FDA Grants Orphan Drug Designation for the Treatment of Bronchiolitis Obliterans

The Lung Transplant Foundation (LTF) has been working diligently to help gain an orphan disease designation for Bronchiolitis Obliterans (BO), the leading cause of morbidity and mortality in the lung transplant population, from the U.S. Food and Drug Administration (FDA) in order to attract therapy development.


The LTF leveraged connections with lung transplant doctors and allied organizations in support of Onspira Therapeutics and its investigatory product, OSP-101, for the treatment of Bronchiolitis Obliterans. The FDA has granted Orphan Drug Designation to OSP-101 for the treatment of Bronchiolitis Obliterans.


“We are very pleased that FDA granted Orphan Drug Designation to OSP-101 for the treatment of Bronchiolitis Obliterans (BO). This is a significant milestone for Onspira, and we look forward to advancing the clinical program in coordination with the FDA and our advisors,” says Jeffrey Goldstein, President and Founding Member, Lung Transplant Foundation.


More than 50 percent of patients develop BO within five years post-transplant and this increases to nearly 80 percent by 10 years. In addition, BO can occur following hematopoietic stem cell transplantation, and it can also be caused by exposure to certain chemicals.


“Advancing the development of novel approaches to the treatment of this terrible condition is a key priority of the Lung Transplant Foundation. We are proud to have played a part in achieving this milestone and look forward to the further development of OSP-101,” Goldstein says.


About the Lung Transplant Foundation

The mission of the Lung Transplant Foundation is to improve the lives of lung transplant patients and families. The is accomplished by promoting and advancing research in order to improve long-term outcomes among lung transplant recipients, educating and promoting awareness about organ donation through patient support, education and advocacy.