LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) said it has resubmitted its biologics license application for MOLBREEVI to the U.S. Food and Drug Administration, a key regulatory step toward approval of a treatment for autoimmune pulmonary alveolar proteinosis, a rare and debilitating lung disease.
The resubmission names FUJIFILM Biotechnologies as the drug substance manufacturer and includes a request for Priority Review, which, if granted, would shorten the FDA’s review timeline. Savara did not disclose a potential decision date.
MOLBREEVI is being developed to treat autoimmune PAP, a chronic condition caused by the abnormal accumulation of surfactant in the lung’s alveoli. In healthy lungs, excess surfactant is cleared by alveolar macrophages, immune cells that rely on stimulation from granulocyte-macrophage colony stimulating factor, or GM-CSF. In autoimmune PAP, antibodies neutralize GM-CSF, impairing macrophage function and allowing surfactant to build up, which disrupts gas exchange and leads to progressive respiratory symptoms.
Patients with the disease commonly experience shortness of breath, fatigue, and cough, with some developing chest pain, fever, or coughing up blood, particularly when secondary infections occur. Over time, autoimmune PAP can lead to serious complications, including lung fibrosis and the potential need for lung transplantation.
MOLBREEVI has already received multiple regulatory designations reflecting its potential clinical importance. The FDA has granted the therapy Fast Track, Breakthrough Therapy, and Orphan Drug designations, while the European Medicines Agency has also designated it as an orphan drug. In the United Kingdom, the Medicines and Healthcare Products Regulatory Agency has awarded MOLBREEVI both an Innovation Passport and Promising Innovative Medicine status.
Savara’s resubmission places the program back into active FDA review and represents a critical milestone for a company focused on rare respiratory diseases with limited treatment options. If approved, MOLBREEVI would address a significant unmet medical need in a small but underserved patient population.
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