MOLBREEVI in aPAP

What is MOLBREEVI?

MOLBREEVI* is a non-glycosylated form of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). Savara is developing an inhaled formulation as a potential treatment option for aPAP. We believe that inhalation of MOLBREEVI activates macrophages in the lung alveoli, thus potentially restoring the surfactant-clearing activity of the alveolar macrophages and considerably improving oxygenation. MOLBREEVI has been granted Orphan Drug Designation for the treatment of aPAP by the U.S. Food and Drug Administration (FDA) and by the European Medicines Agency (EMA), Fast Track Designation and Breakthrough Therapy Designation by the FDA, and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA).

*MOLBREEVI is the FDA and EMA conditionally accepted trade name for molgramostim inhalation solution. It is not approved in any indication.