A new FDA Fast Track designation for Zambon
The designation is for LCsAi for the treatment of bronchiolitis obliterans syndrome, developed by Breath Therapeutics, a Zambon company.
Zambon, a multinational pharmaceutical company that focuses on innovation and development with the aim to improve the quality of people’s health and patients’ lives, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Liposomal Cyclosporine A for Inhalation (LCsAi), in late-stage clinical development for the treatment of Bronchiolitis Obliterans Syndrome (BOS). LCsAi, developed by Breath Therapeutics which was acquired by Zambon in 2019, previously received orphan drug designation from the FDA and European Medicines Agency for the treatment of BOS.
“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 LCsAi represents an important recognition of its potential to address the unmet medical need of patients with BOS, a devastating rare disease with currently no approved treatment,” said Roberto Tascione, Zambon’s CEO.