Anemia Due to Chronic Kidney Disease

• FDA approval · 2026-04-01
  FDA Approved: VAFSEO — Supplemental Application (Akebia Therapeutics, Inc.)

  FDA approved a supplemental application for VAFSEO (vadadustat) from Akebia Therapeutics, Inc. under NDA 215192.

• CLINICAL_TRIALS research · 2026-03-27
  Clinical Trial Update: A Study of AND017 to Evaluate Efficacy and Safety in Patients With Anemia Due to Non-Dialysis-Dependent Chronic Kidney Disease (NDD-CKD) [Phase 3]

  A Phase 3 trial is evaluating AND017 for anemia in non-dialysis-dependent chronic kidney disease and is currently recruiting. Sponsored by K…

• CLINICAL_TRIALS research · 2026-03-27
  Clinical Trial Update: A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia [Phase 3]

  This is a Phase 3 clinical trial evaluating the efficacy and safety of AND017 in dialysis-dependent chronic kidney disease patients with ane…

• FDA approval · 2024-04-30
  FDA Approved: PROCRIT — Supplemental Application (Janssen Products, LP)

  FDA approved Janssen Products, LP's supplemental application for PROCRIT (erythropoietin alfa), updating the drug's labeling.

• FDA approval · 2024-03-27
  FDA Approved: VAFSEO — Original Application (Akebia Therapeutics, Inc.)

  The FDA approved VAFSEO (vadadustat) under an original NDA from Akebia Therapeutics for the treatment of anemia due to chronic kidney diseas…

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• FDA approval · 2023-02-01
  FDA Approved: JESDUVROQ — Original Application (GlaxoSmithKline LLC)

  FDA approved JESDUVROQ (daprodustat) from GlaxoSmithKline in an original application for the treatment of anemia due to chronic kidney disea…

• FDA approval · 2022-08-30
  FDA Approved: MIRCERA — Supplemental Application (Vifor (International) Inc.)

  FDA approves a supplemental application for MIRCERA (methoxy polyethylene glycol-epoetin beta) from Vifor International Inc.

• FDA approval · 2014-10-01
  FDA Approved: MIRCERA — Supplemental Application (Vifor (International) Inc.)

  FDA approved a supplemental application for Mircera (methoxy polyethylene glycol-epoetin beta) submitted by Vifor (International) Inc., repr…

• FDA approval · 2013-03-27
  FDA Approved: PROCRIT — Supplemental Application (Janssen Products, LP)

  FDA approved Janssen Products, LP's supplemental application for PROCRIT (erythropoietin), updating the product labeling under BLA103234.

• FDA approval · 2011-06-24
  FDA Approved: ARANESP — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for ARANESP (darbepoetin alfa) submitted by Amgen, Inc.

• FDA approval · 2008-03-07
  FDA Approved: PROCRIT — Supplemental Application (Janssen Products, LP)

  FDA approved a supplemental application for PROCRIT (epoetin alfa) submitted by Janssen Products, LP.

• FDA approval · 2007-12-17
  FDA Approved: ARANESP — Supplemental Application (Amgen, Inc)

  FDA approved Amgen's supplemental application for ARANESP (darbepoetin alfa), resulting in an updated approval status for the product throug…

• FDA approval · 2007-11-14
  FDA Approved: MIRCERA — Original Application (Vifor (International) Inc.)

  The FDA approved Mircera (methoxy polyethylene glycol-epoetin beta) as an original application for the treatment of anemia associated with c…

• FDA approval · 2007-03-09
  FDA Approved: PROCRIT — Supplemental Application (Janssen Products, LP)

  The FDA approved a supplemental application for PROCRIT (erythropoietin/epoetin alfa) from Janssen Products, LP.

• FDA approval · 2007-03-09
  FDA Approved: ARANESP — Supplemental Application (Amgen, Inc)

  FDA approved a supplemental application for ARANESP (darbepoetin alfa) from Amgen, Inc.

• CLINICAL_TRIALS trial_result · 2006-10-26
  Clinical Trial Update: Efficacy and Safety Study of GerEPO [Phase 3]

  Phase 3 clinical trial update evaluating the efficacy and safety of GerEPO for anemia associated with chronic kidney disease. The study has …