LANGHORNE, PA — Savara Inc. (Nasdaq: SVRA) announced that its updated analysis of U.S. health claims data estimates approximately 5,500 patients are currently diagnosed with autoimmune pulmonary alveolar proteinosis (autoimmune PAP), representing a nearly 50% increase over the company’s previous 2023 estimate of about 3,600 patients.
The revised analysis was conducted by a third-party analytics provider and used a more recent and comprehensive dataset encompassing more than three times the number of records accessed in the prior study. Autoimmune PAP patients were identified using ICD-10 diagnostic codes, recent medical or pharmacy claims, and additional validation criteria, including specialist visits, relevant procedures, and documented symptoms. Autoimmune PAP is the most common form of the disease, accounting for over 90% of all cases.
Braden Parker, Savara’s chief commercial officer, said the increase in identified cases reflects both better data and growing awareness. He noted that the findings “may indicate that awareness and diagnosis rates are accelerating” and emphasized that the company remains focused on improving detection and understanding of this rare lung condition.
Savara is advancing MOLBREEVI, its investigational therapy for autoimmune PAP, and plans to resubmit its Biologics License Application (BLA) to the U.S. Food and Drug Administration in December 2025, requesting priority review. The company also highlighted results from its pivotal Phase 3 IMPALA-2 trial, published in the New England Journal of Medicine, which showed MOLBREEVI’s potential to address the underlying pathophysiology of autoimmune PAP.
“With no approved medicines in the U.S. to treat autoimmune PAP, these claims data reinforce our belief that there is a large unmet medical need,” said Matt Pauls, Savara’s chair and chief executive officer. He added that strong operational execution over the last quarter has positioned the company to move forward with its regulatory plans.
MOLBREEVI has received multiple regulatory designations, including Fast Track and Breakthrough Therapy status from the FDA, Orphan Drug designation from both the FDA and European Medicines Agency, and Innovation Passport and Promising Innovative Medicine designations from the UK’s Medicines and Healthcare Products Regulatory Agency.
Savara’s updated prevalence data and continued progress toward regulatory approval highlight its focus on addressing significant unmet needs in the treatment of autoimmune PAP.
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