Posted by Michael Wonder on 07 May 2019
Savara announces Molgradex received fast track designation by FDA for treatment of auto-immune pulmonary alveolar proteinosis
6 May 2019 - Savara today announced that the U.S. FDA granted fast track designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor.
Molgradex, the Company’s lead product candidate, is being investigated in a pivotal Phase 3 study, called IMPALA, for the treatment of auto-immune pulmonary alveolar proteinosis.
Top-line results from the study are expected in June 2019. Positive results would facilitate the submission of a biologics license application in the first half of 2020, with an anticipated commercial launch later in 2020 or early 2021.
