FDA grants fast track designation to novel drug for bronchiolitis obliterans syndrome
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The FDA has granted fast track designation to liposomal cyclosporine A for inhalation for treatment of bronchiolitis obliterans syndrome, according to a press release.
The treatment is a novel liposomal formulation of cyclosporine A developed for inhaled delivery to the lungs (L-CsA-i, Breath Therapeutics/Zambon) that is administered through a drug-specific investigational nebulizer (eFlow, Pari Pharma GmbH).
“Zambon is committed to its mission of innovating cure and improving the quality of life for people living with severe respiratory diseases worldwide. The FDA’s fast track designation for L-CsA-i represents an important recognition of its potential to address the unmet medical need of patients with bronchiolitis obliterans syndrome, a devastating rare disease with currently no approved treatment,” Roberto Tascione, CEO of Zambon, said in the release.
L-CsA-is currently being evaluated for treatment of bronchiolitis obliterans syndrome in patients aged 6 years and older in the BOSTON clinical development program, which is comprised of five ongoing or planned trials. These include the pivotal phase 3 BOSTON-1 and BOSTON-2 studies in adults with bronchiolitis obliterans syndrome after lung transplantation, the open-label extension BOSTON-3 study, the safety and exploratory efficacy BOSTON-4 study, which is also the first to evaluate the treatment in adults with bronchiolitis obliterans syndrome after allogenic hematopoietic stem cell transplant, and the BOSTON-5 safety study evaluating L-CsA-i in pediatric patients.
“We believe fast track designation provides an opportunity for frequent interactions with the FDA, which may potentially expedite the development and registration of L-CsA-i,” Paola Castellani, chief medical officer of Zambon, said in the release. “We will work closely with the FDA to advance the BOSTON clinical program and accelerate our efforts to develop an effective therapy for the treatment of bronchiolitis obliterans syndrome.”