LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) has initiated the rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI, a potential treatment for a rare lung disease called autoimmune pulmonary alveolar proteinosis (aPAP). This progressive condition causes an abnormal buildup of surfactant in the lungs, leading to debilitating respiratory symptoms.
MOLBREEVI has received key designations from the FDA, including Fast Track and Breakthrough Therapy, both granted in 2019. These designations are reserved for drugs that address serious medical conditions and demonstrate potential advantages over existing therapies. MOLBREEVI has also been awarded Orphan Drug status by both the FDA and the European Medicines Agency (EMA).
The rolling submission allows Savara to file sections of the BLA as they are completed, rather than waiting to submit the entire application, potentially speeding up the overall review process. The company plans to request a priority review of the application and expects to finalize its submission by the end of the first quarter of 2025.
“Given the positive results of the pivotal, Phase 3 IMPALA-2 trial, we believe MOLBREEVI demonstrates a favorable benefit-risk profile and could fundamentally change the way aPAP is treated,” said Matt Pauls, Chair and CEO of Savara. “Initiation of the BLA is an important milestone in potentially addressing the unmet need in aPAP, for which there are no approved medicines in the U.S. and Europe.”
Savara’s proactive regulatory strategy reflects the significant unmet need for treatments addressing aPAP, a disease that currently lacks FDA-approved therapies. The submission marks a step forward in providing an innovative solution for patients and their families while solidifying Savara’s commitment to tackling rare diseases.
For the latest news on everything happening in Chester County and the surrounding area, be sure to follow MyChesCo on Google News and MSN.