Savara Inc., a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced that the European Patent Office has granted patent number 4 496 611, titled “Drug-Device Combination Comprising a Liquid Solution and a Nebulizer for Aerosolization of the Liquid Solution.” The patent, jointly held with PARI, protects the combination of Savara’s investigational therapy MOLBREEVI and PARI’s eFlow Nebulizer System, which has been specifically optimized to deliver MOLBREEVI effectively.

Health Technology Insights: Ryder and BJC Win Award for Healthcare Supply Chain Innovation

Matt Pauls, J.D., M.B.A., Chair and Chief Executive Officer of Savara, stated that the patent provides protection for their drug-device combination through March 2043. He noted that with ten years of Orphan Drug regulatory exclusivity upon European approval and the exclusive license agreement with PARI, the patent ensures long-term protection for MOLBREEVI as a treatment for autoimmune pulmonary alveolar proteinosis in Europe. Pauls added that Savara is preparing to resubmit the MOLBREEVI biologics license application in the U.S. in December and plans to submit marketing authorization applications in Europe and the U.K. in the first quarter of 2026, while also pursuing additional intellectual property protections in Europe, the United States, and other key markets.

Health Technology Insights: Merck Reports Positive Phase 3 Results for DOR/ISL HIV Therapy

MOLBREEVI delivered through the eFlow Nebulizer System has received Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration, Orphan Drug designations from both the FDA and the European Medicines Agency, and Innovation Passport and Promising Innovative Medicine designations from the U.K. Medicines and Healthcare Products Regulatory Agency. Savara plans to market the proprietary eFlow Nebulizer System for use with MOLBREEVI under the name Vespera Nebulizer System following regulatory approval, providing patients with a reliable, optimized delivery system for this rare respiratory therapy.

Health Technology Insights: Medscape Launches AI-Powered Medical Intelligence for HCPs

To participate in our interviews, please write to our HealthTech Media Room at info@intentamplify.com