Also known as: autoimmune PAP
Autoimmune pulmonary alveolar proteinosis (aPAP) is a rare lung disease caused by anti-GM-CSF autoantibodies, leading to surfactant accumulation in alveoli and impaired gas exchange.
The FDA extended by three months the review period for Savara's MOLBREEVI biologics license application in autoimmune pulmonary alveolar proteinosis, moving the PDUFA date to Nov. 22, 2026. Savara had previously said the FDA filed the application after a resubmission tied to manufacturing data and a transfer to Fujifilm.
The FDA has accepted Savara’s BLA for MOLBREEVI in autoimmune PAP and granted Priority Review with an action date of August 22, 2026. The application includes data showing improved pulmonary gas transfer, quality of life, and clinical symptoms.
Savara has submitted a Biologics License Application for MOLBREEVI to the FDA with Priority Review status, targeting an August 22, 2026 decision date for treating autoimmune pulmonary alveolar proteinosis.
The FDA has accepted Savara's Biologics License Application for Molbreevi in autoimmune pulmonary alveolar proteinosis, granted priority review, and set a PDUFA action date of August 22, 2026. The company plans to file marketing authorization applications in the EU and UK by the end of March.
The FDA has filed Savara's biologics license application for MOLBREEVI to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a target action date of August 22, 2026.
Savara Inc. announced the FDA has accepted its Biologics License Application for Molbreevi to treat autoimmune pulmonary alveolar proteinosis, granting Priority Review with a PDUFA action date of August 22, 2026.
Savara Inc. announced the FDA has filed for review the BLA for MOLBREEVI to treat autoimmune PAP, granting Priority Review with a PDUFA action date of August 22, 2026. The therapy could become the first approved treatment for this rare lung disease.
Savara Inc. announced the FDA has accepted its resubmitted Biologics License Application for MOLBREEVI, a treatment for autoimmune pulmonary alveolar proteinosis, with Priority Review granted and a target decision date of August 22, 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06546098 |
Molgramostim Nebulizer Solution Expanded Access Program Protocol |
AVAILABLE | |
| NCT06431776 |
Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP). |
RECRUITING | PHASE3 |
| NCT06111846 |
Study of Human Bone Marrow Mesenchymal Stem Cells in APAP |
ACTIVE_NOT_RECRUITING | PHASE2 |
| NCT04544293 |
Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) |
ACTIVE_NOT_RECRUITING | PHASE3 |
| NCT03531996 |
The Longitudinal Evaluation of Autoimmune Pulmonary Alveolar Proteinosis |
COMPLETED | |
| NCT03482752 |
Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis |
TERMINATED | PHASE3 |
| NCT03231033 |
Pioglitazone Therapy of Autoimmune Pulmonary Alveolar Proteinosis Autoimmune Pulmonary Alveolar Proteinosis |
COMPLETED | PHASE1 |
| NCT03006146 |
Evaluation of a Single Dose of Inhaled Sargramostim in Patients With Autoimmune Pulmonary Alveolar Proteinosis |
COMPLETED | PHASE1 |
| NCT02702180 |
Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis |
COMPLETED | PHASE2 |
| NCT02243228 |
Inhalation of Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) for Autoimmune Pulmonary Alveolar Proteinosis (PAP) |
UNKNOWN | PHASE2 |
