Savara Inc. (NASDAQ: SVRA), an orphan lung disease company, announced that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). Molgradex, the Company’s lead product candidate, is being investigated in a pivotal Phase 3 study, called IMPALA, for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP). Topline results from the study are expected in June 2019. Positive results would facilitate the submission of a Biologics License Application (BLA) in the first half of 2020, with an anticipated commercial launch later in 2020 or early 2021.
The Fast Track program facilitates the expedited development and review of new drugs or biologics that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. A drug granted Fast Track designation may be eligible for Priority Review or Rolling Review of the BLA, if relevant criteria are met.
“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. “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.”
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