Savara's Mogradex is eligible for the FDA's breakthrough drug

. Savara Inc. is a clinically-stage U.S. biopharmaceutical company dedicated to developing and commercializing innovative treatments for rare respiratory diseases that are serious or life-threatening.Recently, the company announced that the U.S. Food and Drug Administration (FDA) has awarded Mologrex Breakthrough Drug Qualification (BTD), a recombinant human granulocyte-macrophage collection stimulant (GM-CSF) inhalation agent for the treatment of autoimmune velebic protein deposition (aPAP).BTD is a new drug review channel created by the FDA in 2012 to accelerate the development and review of new drugs used to treat serious or life-threatening diseases, and there is preliminary clinical evidence that the drug can substantially improve the condition compared to existing treatments. Access to BTD drugs can be developed with closer guidance, including from senior FDA officials, to ensure that new treatment options are available to patients in the shortest possible time.FDA grants Moldex BTD based on data from IMPALA, a critical Phase III clinical study. The study assessed the efficacy and safety of Mogradex's treatment of aPAP, which was recently presented at an oral meeting of the European Respiratory Society (ERS) International Congress in Madrid, Spain.Rob Neville, CEO of Savara, said: "We are pleased that the FDA has awarded Molegradex a breakthrough drug qualification for the treatment of aPAP, a debilitating, rare lung disease that is not approved. We believe that this qualification reflects the importance of Molgradex as a product under study, based on data from the IMPALA study, the drug has been shown to improve the prognosticity of patients. BTD's efforts to strengthen collaboration and more frequent dialogue with the FDA are important milestones in determining the best development path for our product Molgradex is an important candidate for Savara, an inhalation GM-CSF The treatment of autoimmune follicle protein deposition (aPAP) is in Phase III clinical, in addition, the evaluation of Mogradex for chronic NTM lung infection of non-cystic fibrosis (CF) and CF patients in the treatment of NTM lung infection is in Phase IIA clinical. Savara is also developing AeroVanc, an inhalable vancomycin that is in Phase III and is used to treat methicillin-resistant Staphylococcus aureus (MRSA) lung infections in CF patients.
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