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Sargramostim - Bayer HealthCare Pharmaceuticals

Drug Profile

Sargramostim - Bayer HealthCare Pharmaceuticals

Alternative Names: BI 61012; GZ 402664; Leukine; Leukine Liquid; Prokine; Recombinant human GM‑CSF; rhuGM-CSF; sargramostim-biosimilar

Latest Information Update: 12 Nov 2018

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At a glance

  • Originator Amgen
  • Developer Bayer HealthCare Pharmaceuticals Inc.; Cincinnati Children's Hospital Medical Center; National Institute on Aging; Partner Therapeutics; Sanofi Genzyme; University of California at Irvine; University of California at San Francisco; University of Colorado at Denver; University of Texas M. D. Anderson Cancer Center; Virginia Commonwealth University
  • Class Adjuvants; Chemoprotectants; Granulocyte-macrophage colony-stimulating factors
  • Mechanism of Action Granulocyte stimulants; Haematopoiesis stimulants; Macrophage stimulants; Neutrophil stimulants
  • Orphan Drug Status

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

    Yes - Pulmonary alveolar proteinosis
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Acute radiation syndrome; Bone marrow disorders; Neutropenia; Pneumococcal infections; Stem cell mobilisation
  • Phase II Alzheimer's disease; Chronic lymphocytic leukaemia; Prostate cancer; Pulmonary alveolar proteinosis
  • No development reported Malignant melanoma; Ovarian cancer
  • Discontinued Crohn's disease; Follicular lymphoma; Non-Hodgkin's lymphoma

Most Recent Events

  • 06 Nov 2018 Sargramostim - Bayer HealthCare Pharmaceuticals receives Orphan Drug status for Pulmonary alveolar proteinosis in USA
  • 07 Jun 2018 Launched for Acute radiation syndrome (In neonates, In infants, In children, In adolescents, and In adults) in USA (SC)
  • 06 Jun 2018 Registered for Acute radiation syndrome (In neonates, In infants, In children, In adolescents, and In adults) in USA (SC)
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