Press release
Savara Announces European Patent Office (EPO) Intends to Grant a Patent for the Liquid Formulation of MOLBREEVI*
-- Once Granted, the Patent Will Provide Protection for MOLBREEVI in Europe Until March 2041 -- -- Savara Was Also Recently Granted a European Patent
About this update from Savara, Inc.
[{"type":"text","content":"\n-- Once Granted, the Patent Will Provide Protection for MOLBREEVI in Europe Until March 2041 --\n\n-- Savara Was Also Recently Granted a European Patent Covering the Investigational Drug-Device Combination of MOLBREEVI Delivered Via PARI’s Proprietary eFlow® Nebulizer System --\n\n LANGHORNE, Pa.--(BUSINESS WIRE)--\nSavara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced the EPO notified the Company of its intention to grant a patent application covering the liquid formulation of MOLBREEVI, an orally inhaled recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF).\n\n“The liquid formulation and drug-device patents will provide protection in Europe through March 2041 and March 2043, respectively, and strengthen the Company’s intellectual property portfolio for MOLBREEVI, our potentially first-in-class therapy to treat autoimmune PAP,” said Matt Pauls, J.D., M.B.A, Chair and Chief Executive Officer, Savara. “Additionally, upon approval in the EU, MOLBREEVI will have 10 years of Orphan Drug regulatory exclusivity. We expect to resubmit the MOLBREEVI BLA to the FDA this month and are preparing to submit the MAA submissions in the EU and the U.K. by the end of 1Q 2026.”\n\nMOLBREEVI, delivered via the proprietary eFlow® Nebulizer System, has been granted Fast Track and Breakthrough Therapy Designations by the U.S. Food and Drug Administration (FDA), Orphan Drug Designation by the FDA and by the European Medicines Agency (EMA), and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of autoimmune PAP.\n\nAbout Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)\n\nAutoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Surfactant consists of proteins and lipids and is an important physiological substance that lines the alveoli to prevent them from collapsing. In a healthy lung, excess surfactant is cleared and digested by immune cells called alveolar macrophages. Alveolar macrophages need to be stimulated by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly in clearing surfactant, but in autoimmune PAP, GM-CSF is neutr...