MHRA accepts Savara’s MOLBREEVI MAA under accelerated review for autoimmune PAP, with decisions also pending from FDA and EMA across global regulatory submissions.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
Medicines and Healthcare products Regulatory Agency (MHRA) has accepted the Marketing Authorization Application (MAA) for MOLBREEVI from Savara Inc. for the treatment of autoimmune pulmonary alveolar proteinosis. The application was accepted under Accelerated Review, enabling a 150-day assessment timeline. A regulatory decision in the U.K. is expected in the fourth quarter of 2026.
Global regulatory reviews underway
In the United States, the U.S. Food and Drug Administration is reviewing the MOLBREEVI Biologics License Application under Priority Review, with a Prescription Drug User Fee Act target date of August 22, 2026.
In Europe, the Marketing Authorization Application is currently under review by the Committee for Medicinal Products for Human Use, with a decision anticipated in the first quarter of 2027.
Savara’s CEO Matt Pauls stated that regulatory submissions for MOLBREEVI are now under review across the United States, European Union, and United Kingdom, with decisions expected within the next 12 months. He added that the company aims to work with regulators during the review process to address the unmet need in autoimmune PAP with a potential first-in-class therapy.
Regulatory designations
MOLBREEVI has received multiple regulatory designations, including Fast Track and Breakthrough Therapy Designations in the United States. The therapy has also been granted Orphan Drug Designation by both the FDA and the European Medicines Agency. In the United Kingdom, the MHRA has awarded Innovation Passport and Promising Innovative Medicine designations.
About autoimmune pulmonary alveolar proteinosis
Autoimmune Pulmonary Alveolar Proteinosis is a rare lung disorder marked by accumulation of surfactant in the alveoli due to impaired clearance by alveolar macrophages. In this condition, autoantibodies neutralize granulocyte-macrophage colony-stimulating factor (GM-CSF), disrupting macrophage function and gas exchange. Patients commonly experience shortness of breath, cough, and fatigue, and the disease may progress to complications such as lung fibrosis or the need for lung transplantation.
Clinical Trial Basis
MOLBREEVI is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) designed to restore alveolar macrophage function and enhance clearance of accumulated surfactant in patients with autoimmune PAP.
The regulatory submissions to the Medicines and Healthcare products Regulatory Agency, U.S. Food and Drug Administration, and European Medicines Agency are primarily based on results from the Phase 3 IMPALA-2 study of MOLBREEVI in autoimmune pulmonary alveolar proteinosis, which evaluated inhaled molgramostim versus placebo in improving pulmonary gas transfer and disease-related outcomes. The program is supported by earlier clinical data, including the Phase 2/3 IMPALA trial, which demonstrated improvements in lung function and supported continued development of inhaled GM-CSF therapy in this rare lung disease.
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About the Writer
Vennela Reddy, BPharm is a pharmacy graduate with a keen interest in clinical research, pharmacovigilance, and medical writing, with a growing focus on publishable and scientific content development. In her words, she is passionate about translating complex medical data into clear, evidence-based communication.