Savara Inc. initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI, its lead program for the potential treatment of autoimmune pulmonary alveolar proteinosis (aPAP). This marks a critical step in the regulatory pathway towards potential market approval for the chronic and debilitating rare lung disease.
The company expects to complete the BLA submission by the end of the first quarter of 2025 and plans to request a priority review. MOLBREEVI previously received Fast Track and Breakthrough Therapy Designations from the FDA in 2019, which are intended to expedite the development and review of drugs for serious conditions with unmet medical needs.
Matt Pauls, Chair and Chief Executive Officer of Savara, stated that the positive results from the pivotal Phase 3 IMPALA-2 trial support MOLBREEVI's favorable benefit-risk profile. The initiation of the BLA submission is an important milestone in addressing the unmet need in aPAP, a condition for which there are no approved medicines in the U.S. and Europe.
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