Savara's inhaled GM-CSF drug molgradex is qualified as FDA breakthrough drug
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Last Update: 2019-12-31
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Source: Internet
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Author: User
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Savara Inc is a clinical stage US biopharmaceutical company dedicated to the development and commercialization of innovative therapies for severe or life-threatening rare respiratory diseases Recently, the company announced that the U.S Food and Drug Administration (FDA) has granted molgradex breakthrough drug qualification (BTD), a recombinant human granulocyte macrophage colony stimulating factor (GM-CSF) inhalation preparation for the treatment of autoimmune alveolar proteinosis (APAP) BTD is a new drug review channel established by FDA in 2012 It aims to accelerate the development and review of new drugs for the treatment of serious or life threatening diseases and there is preliminary clinical evidence that the drug can substantially improve the condition compared with existing treatment drugs The drugs that obtain BTD can receive more close guidance, including FDA senior officials, during the research and development, so as to guarantee to provide patients with new treatment options in the shortest time FDA awarded molgradex BTD based on data from the critical phase III clinical study impala The study assessed the efficacy and safety of molgradex in the treatment of APAP, and data were recently presented at the oral meeting of the European Respiratory Society (ERs) International Conference 2019 in Madrid, Spain.
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