Samumed said today that the FDA awarded orphan drug status to its inhaled idiopathic pulmonary fibrosis therapy, SMo4646.
The IPF therapy is administered using a nebulizer and can be used as a montherapy or in combination with pirfenidone or nintedanib, according to the San Diego-based company.
“The FDA’s decision to grant an ODD to SM04646 for IPF is another important milestone in the development of SM04646,” chief medical officer Yusuf Yazici said in prepared remarks. “IPF is a chronic, progressive, fibrotic disorder that causes deteriorating lung function and severe dyspnea in patients and ultimately ends in fatality. Early trials demonstrate the therapeutic potential of SM04646 to help address the unmet medical need of individuals with IPF.”
Earlier this month, Samumed said it finished its Phase I study of SM04646 and that the therapy was safe and well-tolerated.