Savara’s MOLBREEVI BLA for autoimmune pulmonary alveolar proteinosis advances in FDA review with a PDUFA decision date of August 22, 2026 and no advisory committee meeting planned.
Written By: Marka Sheshi, PharmD
Reviewed By: Pharmacally Editorial Team
Savara Inc., a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced that the U.S. Food and Drug Administration has issued a Day 74 Letter for the Biologics License Application (BLA) of MOLBREEVI, an investigational therapy for autoimmune pulmonary alveolar proteinosis (autoimmune PAP).
A Day 74 Letter is an FDA communication issued roughly 74 days after submission of a Biologics License Application (BLA) or New Drug Application (NDA) confirming that the filing has been accepted for full review and outlining key elements of the regulatory review process, including the PDUFA decision timeline, according to FDA guidance on the filing review process.
The agency confirmed that it does not currently plan to convene an advisory committee meeting, and the review remains ongoing with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026.
MOLBREEVI is being developed as a potential first-in-class treatment for autoimmune PAP, a rare and debilitating lung disorder for which no approved therapies currently exist in the United States or Europe.
The therapy has received multiple regulatory designations intended to support its development and review, including Fast Track and Breakthrough Therapy Designations from the FDA, as well as Orphan Drug Designation from both the FDA and the European Medicines Agency (EMA).
In the United Kingdom, the therapy has also been granted an Innovation Passport and Promising Innovative Medicine (PIM) designation by the Medicines and Healthcare products Regulatory Agency (MHRA).
Savara is also advancing global regulatory submissions for the therapy. The company recently submitted a Marketing Authorization Application (MAA) to the EMA for MOLBREEVI in autoimmune PAP and plans to submit an additional MAA to the U.K.’s MHRA by the end of the first quarter of 2026.
“MOLBREEVI has the potential to be a first-in-class treatment for autoimmune PAP, a rare and debilitating lung disease with no approved therapeutics in the U.S. and Europe,” said Matt Pauls, Chair and Chief Executive Officer of Savara. He added that the company remains confident in the therapy’s potential to address a significant unmet medical need and looks forward to working with regulatory authorities during the review process.
Autoimmune pulmonary alveolar proteinosis is characterized by the abnormal accumulation of surfactant within the lung alveoli. Surfactant, composed of proteins and lipids, normally helps keep the alveoli open and supports efficient gas exchange.
In healthy lungs, excess surfactant is cleared by immune cells known as alveolar macrophages, which require stimulation by granulocyte-macrophage colony-stimulating factor (GM-CSF) to function properly. In autoimmune PAP, antibodies neutralize GM-CSF, impairing macrophage activity and preventing adequate surfactant clearance.
The resulting buildup disrupts gas exchange and can lead to symptoms such as shortness of breath, persistent cough, fatigue, and recurrent respiratory infections. Over time, the disease may progress to severe complications including lung fibrosis and the potential need for lung transplantation.
References
Savara Provides Regulatory Update on the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP), 06 March 2026, https://investors.savarapharma.com/news/news-details/2026/Savara-Provides-Regulatory-Update-on-the-MOLBREEVI-Development-Program-in-Autoimmune-Pulmonary-Alveolar-Proteinosis-Autoimmune-PAP/default.aspx
PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2018 Through 2022, https://www.fda.gov/media/99140/download
About Writer
Marka Sheshi | Doctor of Pharmacy
Driven by a deep commitment to clinical excellence, research integrity, and impactful medical writing. With a strong foundation in pharmacotherapy and patient safety, specializes in transforming complex scientific evidence into authoritative, publication-ready content. Passionate about advancing healthcare through precise, evidence-based communication that informs practice, strengthens research visibility, and improves patient outcomes.