Posted by Michael Wonder on 28 Apr 2020
A new FDA fast track designation for Zambon
28 April 2020 - The designation is for L‑CsA‑i for the treatment of bronchiolitis obliterans syndrome, developed by Breath Therapeutics, a Zambon company.
Zambon today announced that the U.S. FDA has granted fast track designation to Liposomal Cyclosporine A for Inhalation (L‑CsA‑i), in late-stage clinical development for the treatment of Bronchiolitis Obliterans Syndrome (BOS).
L‑CsA‑i, 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.
