According to Savara, the MHRA has accepted the company’s marketing application for Molbreevi molgramostim inhalation solution for the treatment of autoimmune pulmonary alveolar proteinosis for accelerated review, with a decision expected by the end of this year. Molbreevi has previously received Promising Innovative Medicine designation and Innovation Passport designation from the MHRA.
In February 2026, Savara announced that the FDA had accepted the company’s BLA for Molbreevi for priority review, with a decision date set for August 2026. The company says that the EMA’s Committee for Medicinal Products for Human Use (CHMP) is also currently reviewing an MAA for Molbreevi.
Savara Chair and CEO Matt Pauls commented, “Marketing applications for Molbreevi in autoimmune PAP are now being reviewed by regulatory agencies across the US, EU, and the UK, all with decisions expected over the next 12 months. We look forward to working with these regulators through the review process as we endeavor to address the unmet need in this rare and chronic lung disease by bringing a first-in-class therapy to autoimmune PAP patients living in these geographies.”
Read the Savara press release
