Biopharma
Savara resubmits FDA application for potential treatment in rare lung disease patients
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer
- By IPP Bureau
| January 01, 2026
Savara has resubmitted its Biologics License Application (BLA) to the US Food and Drug Administration for its potential treatment for autoimmune pulmonary alveolar proteinosis (autoimmune PAP), a rare lung disease.
The resubmission of BLA for MOLBREEVI names Fujifilm as the drug substance manufacturer, addressing a key component of the filing.
The clinical-stage biopharmaceutical company is seeking Priority Review, a designation that could significantly accelerate the agency’s evaluation of the therapy.
MOLBREEVI has already secured multiple regulatory endorsements underscoring its potential importance for patients with limited treatment options.
The drug has received Fast Track and Breakthrough Therapy designations from the FDA, Orphan Drug designation from both the FDA and the European Medicines Agency, and Innovation Passport and Promising Innovative Medicine status from the UK’s Medicines and Healthcare Products Regulatory Agency.
Autoimmune PAP is caused by a failure of the lungs to clear surfactant — a substance essential to keeping air sacs open — due to antibodies that neutralize a key immune signaling protein, GM-CSF. The resulting buildup impairs oxygen exchange and leads to symptoms such as shortness of breath, chronic fatigue, cough, and recurrent infections.
Savara’s resubmission marks a critical step forward in its effort to bring a targeted therapy to patients living with this rare and serious condition.
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