According to Zambon, the FDA has granted Fast Track designation to the company’s liposomal cyclosporine A for inhalation (L‑CsA‑i), which is in Phase 3 development for the treatment of bronchiolitis obliterans syndrome (BOS). Zambon acquired L‑CsA‑i developer Breath Therapeutics, a spin off of PARI Pharma, in July 2019. L-CsA-i has already received orphan drug designation from both the FDA and EMA for the treatment of BOS.
Zambon Chief Medical Officer Paola Castellani said, “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. 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 BOS.”
CEO Roberto Tascione commented, “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 BOS, a devastating rare disease with currently no approved treatment.”
Read the Zambon press release.
