Posted by Michael Wonder on 31 Dec 2019
Savara granted breakthrough therapy designation for Molgradex for the treatment of auto-immune pulmonary alveolar proteinosis
30 December 2019 - Savara today announced that the U.S. FDA has granted breakthrough therapy designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of aPAP.
The Molgradex breakthrough therapy designation is based on data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex for the treatment of aPAP.
Data from the study was recently presented in an oral session at the 2019 European Respiratory Society International Congress in Madrid, Spain.
