Savara has announced two new European patents covering Molbreevi molgramostim inhalation solution. The company said that it has received notification from the European Patent Office that it intends to grant a patent covering the liquid formulation of Molbreevi and recently was granted Patent No. 4 496 611 (“Drug-Device Combination Comprising a Liquid Solution and a Nebulizer for Aerosolization of the Liquid Solution”) covering the combination of Molbreevi and PARI’s eFlow nebulizer.
A rolling BLA submission for Molbreevi for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP) that was initiated in December 2024 was completed in March 2025. The FDA issued a Refuse to File letter to the application in May 2025.
In Europe, Molbreevi has received orphan drug designation from the EMA. In the UK, the MHRA has granted the product Innovation Passport and Promising Innovative Medicine designations. In the US, Molbreevi has been granted Breakthrough Therapy and Fast Track designations by the FDA.
Savara Chair and CEO Matt Pauls commented, “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. 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 UK by the end of 1Q 2026.”
Read the Savara press release
