Savara’s Persistence May Pay Off In Rare Lung Disease

 
• By Joseph Haas
  
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Five years after a Phase III failure, Savara reports pivotal data supporting approval of molgramostim as the first drug for autoimmune pulmonary alveolar proteinosis.

Alveoli
Savara is trying to bring a first approved drug for a rare alveoli disorder • Source: Shutterstock

Despite an earlier Phase III failure, Savara Inc. has stuck with its goal to bring recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) to approval in autoimmune pulmonary alveolar proteinosis (aPAP), and on 26 June reported positive Phase III results for molgramostim that it said support global filings in the rare lung disease in early 2025.

Key Takeaways

  • Savara succeeded in the Phase III IMPALA-2 study of molgramostim in aPAP, a rare lung disorder, five years after a previous Phase III study missed its primary endpoint.

The data from the study, IMPALA-2, came a little more than five years after Savara tried to present a prior...

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