Savara to Present Phase 3 IMPALA-2 Trial Data on Molgramostim for Rare Lung Disease at Multiple International Conferences
• Savara will showcase new data from its pivotal Phase 3 IMPALA-2 trial of molgramostim for autoimmune pulmonary alveolar proteinosis (aPAP) at the American Thoracic Society International Conference in May 2025.
• Two poster presentations will highlight how molgramostim reduces surfactant burden, decreases whole lung lavage procedures, and improves respiratory health-related quality of life in aPAP patients.
• The company will host an Industry Theater featuring world-renowned experts Dr. Bruce Trapnell and Dr. Cormac McCarthy to discuss advances in aPAP diagnosis and management.
Savara Initiates FDA Submission for MOLBREEVI in Rare Lung Disease
• Savara Inc. has begun a rolling submission of a Biologics License Application (BLA) to the FDA for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis (aPAP).
• MOLBREEVI has received Fast Track, Breakthrough Therapy, and Orphan Drug Designations, potentially expediting its review and approval process.
• The company anticipates completing the BLA submission by the end of Q1 2025 and will request a priority review for the treatment.
• Phase 3 trial data supports MOLBREEVI's favorable benefit-risk profile, offering a potential first-in-class treatment for aPAP in the U.S. and Europe.
Savara's Molgramostim Shows Promise in Autoimmune Pulmonary Alveolar Proteinosis
• Savara Inc. presented results from the Phase 3 IMPALA-2 trial of molgramostim inhalation solution for autoimmune pulmonary alveolar proteinosis (aPAP).
• The presentation highlighted molgramostim's ability to improve pulmonary gas exchange and respiratory health-related quality of life in aPAP patients.
• The data was presented at the British Thoracic Society Winter Meeting 2024, with slides available on Savara's website.
• Molgramostim is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) delivered via eFlow Nebulizer System.
Savara's Molgramostim Shows Promise in Autoimmune Pulmonary Alveolar Proteinosis
• Savara Inc. announced an encore presentation of Phase 3 IMPALA-2 trial results for Molgramostim at the British Thoracic Society Winter Meeting 2024.
• The IMPALA-2 trial demonstrated that inhaled Molgramostim improves pulmonary gas exchange in patients with autoimmune Pulmonary Alveolar Proteinosis (aPAP).
• Dr. Cormac McCarthy presented data showing Molgramostim also enhances respiratory health-related quality of life in aPAP patients.
• The presentation slides will be available on Savara's corporate website following the session on November 29, 2024.
Savara Announces Presentation of Phase 3 IMPALA-2 Trial Results for Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
• Savara Inc. will present results from the Phase 3 IMPALA-2 trial of inhaled molgramostim at the British Thoracic Society Winter Meeting.
• The presentation will highlight molgramostim's impact on improving pulmonary gas exchange and respiratory health-related quality of life in aPAP patients.
• The IMPALA-2 trial evaluated molgramostim, a recombinant human GM-CSF, delivered via eFlow Nebulizer, for treating autoimmune pulmonary alveolar proteinosis.
• Following the presentation on November 29, the slides will be available on Savara's website for further review.
Savara Plans Rolling Submission to FDA for MOLBREEVI in Autoimmune Pulmonary Alveolar Proteinosis
• Savara plans to initiate a rolling submission of the Biologics License Application (BLA) to the FDA for MOLBREEVI by the end of the year.
• The company anticipates completing the BLA submission by the end of Q1 2025 and intends to request priority review for potential U.S. approval by late 2025.
• Savara expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) by the end of 2025.
• With approximately $219 million in cash, Savara believes it is sufficiently funded through the second quarter of 2027.
Savara Launches Expanded Access Program for Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
• Savara Inc. has initiated an Expanded Access Program (EAP) for molgramostim inhalation solution to treat autoimmune pulmonary alveolar proteinosis (aPAP) in select regions.
• The FDA has reviewed and allowed the Savara Early Access Program to proceed, currently accepting requests from eligible patients in North America and Europe.
• Savara plans to submit a Biologics License Application (BLA) to the FDA for molgramostim in aPAP in the first half of 2025, marking a key regulatory milestone.
• Molgramostim has received multiple designations, including Orphan Drug, Fast Track, and Breakthrough Therapy, from regulatory agencies for aPAP treatment.
Molgramostim Shows Sustained Benefits in Phase 3 Trial for Autoimmune Pulmonary Alveolar Proteinosis
• Molgramostim demonstrated a statistically significant improvement in lung diffusing capacity (DLCO%) at Week 24, which was sustained through Week 48 in aPAP patients.
• The IMPALA-2 trial showed molgramostim significantly improved disease severity scores and ground glass opacification, indicative of reduced surfactant burden.
• Responder analysis revealed higher proportions of patients achieving clinically meaningful improvements in DLCO% and respiratory questionnaire scores with molgramostim.
• Savara plans to submit a Biologics License Application (BLA) for molgramostim in the first half of 2025, seeking approval for aPAP treatment.
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