LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has announced the completion of its Biologics License Application (BLA) submission to the U.S. Food and Drug Administration (FDA) for MOLBREEVI, a potential treatment for autoimmune pulmonary alveolar proteinosis (aPAP), a rare and debilitating lung condition. The company has also requested Priority Review, which, if granted, could reduce the FDA review timeline from 10 months to 6 months.
“Submission of the BLA marks an important milestone for the Company and the aPAP community,” said Matt Pauls, Chair and Chief Executive Officer of Savara. “We believe this unprecedented body of data demonstrates MOLBREEVI improves pulmonary gas exchange and the clinical symptoms associated with this rare lung disease. We are grateful to the patients and physicians who participated in our clinical trials.”
Promising Trial Results
Key findings from the IMPALA-2 clinical trial highlight MOLBREEVI’s potential impact. The therapy significantly improved percent predicted diffusing capacity of the lungs for carbon monoxide (DLCO), a critical measure of pulmonary gas exchange, at Week 24 compared to a placebo. This improvement was sustained at Week 48, confirming MOLBREEVI’s durable treatment effect.
The trial also showed clinical benefits across secondary endpoints:
- Improvement in St. George’s Respiratory Questionnaire (SGRQ) Total Scores, measuring quality of life.
- Gains in SGRQ Activity Scores and Exercise Capacity, measured using the treadmill-based METs system.
MOLBREEVI demonstrated strong tolerability, with 97% of patients completing the trial and no drug-related adverse event discontinuations reported.
Regulatory Designations and Next Steps
MOLBREEVI has received multiple regulatory designations that reflect its innovative potential. These include Fast Track, Breakthrough Therapy, and Orphan Drug Designations from the FDA, as well as Orphan Drug Designation from the European Medicines Agency (EMA). The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has also granted MOLBREEVI Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations.
Savara expects the commercial launch of MOLBREEVI in early 2026, contingent upon FDA approval. “Our commercial preparations are on track to support a potential launch,” Pauls noted. “This submission solidifies our commitment to advancing care for rare lung disease patients.”
With regulatory dialogue ongoing and clinical data to support its application, MOLBREEVI represents a major step forward in addressing unmet needs in the aPAP community.
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