The FDA has granted Fast Track designation to Renovion’s ARINA-1 nebulized mucolytic for the prevention of bronchiolitis obliterans syndrome in patients who have had a bilateral lung transplant, which will allow the company to take advantage of a rolling NDA submission, Renovion said. In August 2022, the company announced that it had received a Study May Proceed notice for the Phase 3 ALOFT trial of ARINA-1 in adult patients who are more than one year post-transplant and who have begun to develop symptoms of BOS.
Renovion Chief Medical Officer Marty Zamora commented, “We are pleased with the FDA’s decision to grant Fast Track designation for ARINA-1 in bilateral lung transplant patients with early BOS, and we look forward to enrolling our first patient in the next few weeks. This allowance complements our orphan drug status in lung transplant and current focus on enrollment at lung transplant centers across the US in the ALOFT trial. This advances our clinical strategy to develop therapies for patients with a critical unmet need. The safety of this drug to date and the efficacy in this trial can make a tremendous difference in the lives of patients with limited or no treatment options.”
In addition to the lung transplant indication, Renovion is developing ARINA-1 for the treatment of non-CF bronchiectasis, for NTM lung disease, and in patients with tracheostomy.
Read the Renovion press release.
