AUSTIN, Texas–(BUSINESS WIRE)–Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced the response from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Molgradex development program for autoimmune pulmonary alveolar proteinosis (aPAP). Molgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF).
In the written response received by Savara on October 1, the FDA indicated that the data provided in the briefing package do not provide sufficient evidence of efficacy and safety and did not recommend that the Company submit a Biologics License Application (BLA). The Company is working to determine the next steps for the Molgradex development program.
“While we are disappointed in the FDA’s response, considering the IMPALA study results presented today at the ERS annual conference, we remain committed to the Molgradex development program and believe that it will provide aPAP patients with a meaningful treatment option,” said Rob Neville, Chief Executive Officer, Savara. “Our priority is to further assess the content of the FDA’s feedback and determine the best development path forward.”
As noted above, additional data from the IMPALA study were presented today at the 2019 European Respiratory Society (ERS) International Congress in Madrid, Spain. The data were presented in an oral session by Bruce Trapnell, M.D., lead Principal Investigator in the U.S. and Director, Translational Pulmonary Science Center, Scientific Director, PAP Foundation, Co-Director, Rare Lung Diseases Clinical Research Consortium, and Professor of Medicine and Pediatrics, University of Cincinnati College of Medicine. Slides from the presentation were attached to Savara’s Form 8-K dated October 2, 2019 and will be posted to the Investor Relations section of the Company’s website.
Savara is an orphan lung disease company. Savara’s pipeline comprises Molgradex, an inhaled granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (aPAP), in Phase 2a development for nontuberculous mycobacterial (NTM) lung infection in both non-cystic fibrosis (CF) and CF-affected individuals with chronic NTM lung infection; and AeroVanc, a Phase 3-stage inhaled vancomycin for treatment of persistent methicillin-resistant Staphylococcus aureus (MRSA) lung infection in CF. Savara’s strategy involves expanding its pipeline of potentially best-in-class products through indication expansion, strategic development partnerships and product acquisitions, with the goal of becoming a leading company in its field. Savara’s management team has significant experience in orphan drug development and pulmonary medicine, identifying unmet needs, developing and acquiring new product candidates, and effectively advancing them to approvals and commercialization. More information can be found at www.savarapharma.com. (Twitter: @SavaraPharma, LinkedIn: www.linkedin.com/company/savara-pharmaceuticals/)