The FDA granted Savara’s (NASDAQ:SVRA) Molgradex fast track designation for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).
aPAP occurs when the body’s immune system attacks granulocyte-macrophage colony stimulating factor (GM-CSF), a protein that clears surfactant from the pulmonary alveoli. The buildup of surfactant causes difficulty breathing, which can be fatal.
“With the potential for priority or rolling review, we are optimistic about the opportunity to accelerate the submission of Molgradex on behalf of patients with this devastating disease,” Rob Neville, Savara’s CEO, said in a statement.
Molgradex, an inhaled formulation of recombinant human GM-CSF, is being studied in a Phase 3 pivotal trial. Savara expects to report top-line data from this trial in June 2019.
