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Eflapegrastim - Hanmi Pharmaceutical/Spectrum Pharmaceuticals

Drug Profile

Eflapegrastim - Hanmi Pharmaceutical/Spectrum Pharmaceuticals

Alternative Names: HM-10460A; HNK-460; LAPS-GCSF; Long-acting G-CSF analogue; ROLONTIS; SPI-2012

Latest Information Update: 31 Oct 2019

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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

  • Preregistration Neutropenia

Most Recent Events

  • 24 Oct 2019 Spectrum Pharmaceuticals resubmits BLA for Neutropenia (Chemotherapy-induced) to the US FDA
  • 24 Oct 2019 Spectrum Pharmaceuticals announces its intention to resubmit the BLA for eflapegrastim for Neutropenia to the US FDA in the fourth quarter of 2019
  • 02 Jun 2019 Integrated efficacy and safety data from the two phase III trials ADVANCE and RECOVER presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO-2019)
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