Eflapegrastim - Hanmi Pharmaceutical/Spectrum Pharmaceuticals

Drug Profile

Eflapegrastim - Hanmi Pharmaceutical/Spectrum Pharmaceuticals

Alternative Names: Granulocyte colony-stimulating factor long-acting - Hanmi Pharmaceutical/Spectrum; Granulocyte colony-stimulating factor long-acting - Spectrum Pharmaceuticals; HM-10460A; HNK-460; LAPS-GCSF; Long-acting G-CSF analogue; ROLONTIS; SPI-2012

Latest Information Update: 05 Jul 2018

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At a glance

  • Originator Hanmi Pharmaceutical
  • Developer Hanmi Pharmaceutical; Spectrum Pharmaceuticals
  • Class Chemoprotectants; Granulocyte colony-stimulating factors; Immunoglobulin Fc fragments; Polyethylene glycols; Small molecules
  • Mechanism of Action Granulocyte stimulants; Haematopoiesis stimulants
  • Orphan Drug Status

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

  • New Molecular Entity No

Highest Development Phases

  • Phase III Neutropenia

Most Recent Events

  • 09 Aug 2018 Spectrum Pharmaceuticals plans a pre-BLA meeting with the US FDA for Eflapegrastim in third quarter of 2018
  • 29 Jun 2018 Updated adverse events and efficacy data from the phase III ADVANCE trial in Neutropenia released by Spectrum Pharmaceuticals
  • 16 May 2018 Adverse events and efficacy data from the phase III ADVANCE trial in Neutropenia released by Spectrum Pharmaceuticals
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