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Molgramostim - Savara Pharmaceuticals

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Drug Profile

Molgramostim - Savara Pharmaceuticals

Alternative Names: GM-CSF inhalation - Savara; MOLBREEVI; Molgradex; Nebulised recombinant human GM-CSF - Savara; NPC 23; rh-GM-CSF

Latest Information Update: 09 Apr 2025

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At a glance

  • Originator Serendex Pharmaceuticals
  • Developer Justus Liebig University Giessen; Savara Pharmaceuticals
  • Class Antibacterials; Antibronchitics; Antifibrotics; Antineoplastics; Chemoprotectants; Immunotherapies; Recombinant proteins
  • Mechanism of Action Granulocyte macrophage colony stimulating factor replacements
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pulmonary alveolar proteinosis; Adult respiratory distress syndrome
  • New Molecular Entity No

Highest Development Phases

  • Preregistration Pulmonary alveolar proteinosis
  • Phase II Adult respiratory distress syndrome; SARS-CoV-2 acute respiratory disease
  • Discontinued Bronchiectasis; Cystic fibrosis; Nontuberculous mycobacterium infections

Most Recent Events

  • 26 Mar 2025 Savara Pharmaceuticals anticipates approval from the US FDA for Molgramostim for the treatment of autoimmune pulmonary alveolar proteinosis by the end of 2025
  • 26 Mar 2025 Savara Pharmaceuticals anticipates completing the submission of Marketing Authorization Application (MAA) for Molgramostim for Pulmonary alveolar proteinosis (aPAP) in Europe, by the end of 2025
  • 26 Mar 2025 Savara Pharmaceuticals completes submission of the BLA to the US FDA for molgramostim for Pulmonary alveolar proteinosis in USA

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