The Food and Drug Administration (FDA) has granted Fast Track designation to Molgradex (molgramostim; Savara) for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), a rare lung disease characterized by the accumulation of surfactant in the airways.
Molgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). The Company is currently conducting a phase 3 trial (IMPALA) of the treatment in 135 aPAP patients; topline results are expected in June 2019.
“We are excited by this designation as it reinforces that a better treatment option is needed for people living with aPAP,” said Rob Neville, Chief Executive Officer, Savara. Currently, there are no pharmacological treatments approved for aPAP; whole lung lavage is considered the standard first-line therapy.
Molgradex is also being evaluated for the treatment of nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection.
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