Summary of Savara’s U.S. Expanded Access Policy
MOLGRADEX (inhaled granulocyte-macrophage colony-stimulating factor, or GM-CSF) is being evaluated for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP).
AEROVANC (vancomycin hydrochloride inhalation powder) for the treatment of persistent methicillin-resistant Staphylococcus aureus, or MRSA, lung infection in cystic fibrosis (CF).
Molgradex – aPAP
Molgradex is the first inhaled GM-CSF being developed for the treatment of a rare respiratory disease called autoimmune pulmonary alveolar proteinosis (aPAP). A pivotal Phase 3 clinical study, called IMPALA, was completed in 2019. The press release announcing results from the 24-week, double-blind period of the study can be found here. The press release announcing results from the open-label period can be found here. A second Phase 3 study is being planned.
AeroVanc – MRSA in CF
AeroVanc was the first inhaled antibiotic being developed to address the growing problem of chronic methicillin-resistant Staphylococcus aureus (MRSA) lung infection in people with CF. On December 10, 2020, Savara disclosed top line data from the double-blind period of the study. Results can be found here. The open-label period of the study is ongoing.
Savara Nasdaq Opening Bell Ceremony - July 23, 2018×