LANGHORNE, PA — Savara Inc. (NASDAQ: SVRA) said European patent authorities have moved to grant a key patent covering the liquid formulation of its investigational lung therapy MOLBREEVI, strengthening the company’s intellectual property position as it advances toward regulatory filings in the United States and Europe.
The company said the European Patent Office has notified Savara of its intention to grant the patent, which would protect MOLBREEVI in Europe through March 2041 once finalized. The decision follows a recently granted European patent covering the drug-device combination of MOLBREEVI delivered through PARI’s proprietary eFlow nebulizer system, extending protection for that technology through March 2043.
Savara Chair and Chief Executive Officer Matt Pauls said the patents significantly reinforce the company’s long-term strategy for MOLBREEVI, which is being developed as a potential first-in-class treatment for autoimmune pulmonary alveolar proteinosis, or autoimmune PAP. He said the company expects to resubmit its biologics license application to the U.S. Food and Drug Administration this month and is preparing marketing authorization applications in the European Union and the United Kingdom by the end of the first quarter of 2026.
Beyond patent protection, MOLBREEVI is positioned to benefit from regulatory exclusivity. If approved in the EU, the therapy would be eligible for ten years of orphan drug exclusivity. In the United States, the drug has already received Fast Track and Breakthrough Therapy designations from the FDA, along with orphan drug status from both U.S. and European regulators. U.K. authorities have also granted Innovation Passport and Promising Innovative Medicine designations.
MOLBREEVI is an inhaled recombinant human granulocyte-macrophage colony-stimulating factor, or GM-CSF, delivered via a nebulizer designed to target the lungs directly. The therapy is intended to address the underlying disease mechanism of autoimmune PAP, a rare and serious condition in which antibodies neutralize GM-CSF, preventing immune cells in the lungs from clearing excess surfactant.
Autoimmune PAP leads to the accumulation of surfactant in the air sacs of the lungs, impairing oxygen exchange and causing symptoms such as shortness of breath, fatigue, and chronic cough. Over time, the disease can progress to lung fibrosis and, in severe cases, the need for lung transplantation.
For Savara, the pending patent grant represents more than legal protection. It provides a longer runway to commercialize a therapy aimed at a small but underserved patient population, while reinforcing the company’s position as it approaches critical regulatory milestones on both sides of the Atlantic.
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