LANGHORNE, Pa. — Savara Inc. said it has resubmitted a Biologics License Application to the U.S. Food and Drug Administration for MOLBREEVI as a potential treatment for autoimmune pulmonary alveolar proteinosis, a rare and debilitating lung disease.
The resubmitted application lists FUJIFILM Biotechnologies as the drug substance manufacturer. Savara said it has also requested Priority Review for the application.
MOLBREEVI is being developed for the treatment of autoimmune pulmonary alveolar proteinosis, a chronic condition caused by the abnormal accumulation of surfactant in the alveoli, which impairs gas exchange and leads to progressive respiratory symptoms. The disease is associated with shortness of breath, cough, fatigue, and increased risk of infection, and in severe cases can result in lung fibrosis or the need for lung transplantation.
The FDA has previously granted MOLBREEVI Fast Track and Breakthrough Therapy designations. The therapy has also received Orphan Drug designation from both the FDA and the European Medicines Agency, as well as Innovation Passport and Promising Innovative Medicine designations from the UK’s Medicines and Healthcare Products Regulatory Agency.
Autoimmune pulmonary alveolar proteinosis occurs when antibodies neutralize granulocyte-macrophage colony-stimulating factor, a key signaling molecule required for alveolar macrophages to clear excess surfactant from the lungs. Without effective clearance, surfactant builds up in the alveoli, leading to impaired oxygen exchange and progressive respiratory dysfunction.
Savara said MOLBREEVI is a recombinant human granulocyte-macrophage colony-stimulating factor designed to address the underlying cause of autoimmune pulmonary alveolar proteinosis. The therapy is delivered via an investigational eFlow nebulizer system developed specifically for inhaled administration.
Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases and said it remains committed to advancing MOLBREEVI toward potential approval and commercialization for patients with autoimmune pulmonary alveolar proteinosis.
