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Roxadustat - FibroGen

Drug Profile

Roxadustat - FibroGen

Alternative Names: ASP 1517; AZD 9941; Evrenzo; FG-4592

Latest Information Update: 31 Dec 2020

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At a glance

  • Originator FibroGen
  • Developer Astellas Pharma; AstraZeneca; FibroGen
  • Class Amides; Antianaemics; Carboxylic acids; Isoquinolines; Small molecules
  • Mechanism of Action Hypoxia-inducible factor-proline dioxygenase inhibitors
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Anaemia
  • Phase II Chemotherapy-induced anaemia
  • Discontinued Sickle cell anaemia

Most Recent Events

  • 18 Dec 2020 FDA assigns PDUFA action date of 20/03/2021 for roxadustat for Anaemia in USA (PO)
  • 18 Dec 2020 US FDA extends review period of NDA for roxadustat for Anaemia
  • 05 Dec 2020 Pooled efficacy data from three phase III OLYMPUS, ANDES, ALPS trials in Anaemia presented at the 62nd Annual Meeting and Exposition of the American Society of Hematology (ASH-Hem-2020)
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