Molidustat

Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

Retrieved on: 
Friday, June 25, 2021

Todays positive CHMP opinion marks a significant step in providing patients with a new and important treatment option for anemia associated with CKD, regardless of dialysis status, saidBernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas.

Key Points: 
  • Todays positive CHMP opinion marks a significant step in providing patients with a new and important treatment option for anemia associated with CKD, regardless of dialysis status, saidBernhardt G. Zeiher, M.D., Chief Medical Officer, Astellas.
  • We look forward to the review and assessment by the European Commission which, if positive, would make roxadustat the first HIF-PH inhibitor approved in Europe to treat symptomatic anemia in adult patients with CKD.
  • Roxadustat is also in Phase 3 clinical development for anemia associated with myelodysplastic syndromes (MDS) and Phase 2 for chemotherapy-induced anemia (CIA).
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).

Astellas Receives Positive CHMP Opinion for EVRENZO™ (roxadustat) for Adult Patients with Symptomatic Anemia of Chronic Kidney Disease

Retrieved on: 
Friday, June 25, 2021

The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).

Key Points: 
  • The Company is currently developing and commercializing roxadustat, an oral small molecule inhibitor of HIF prolyl hydroxylase activity, for anemia associated with chronic kidney disease (CKD).
  • Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data.
  • Anemia and iron deficiency among chronic kidney disease Stages 3-5ND patients in the Chronic Kidney Disease Outcomes and Practice Patterns Study: often unmeasured, variably treated.
  • Anemia in Chronic Kidney Disease: National Institute of Diabetes and Digestive and Kidney Disease.

FibroGen Provides Regulatory Update on Roxadustat

Retrieved on: 
Monday, March 1, 2021

While disappointed with the news today, FibroGen and AstraZeneca are committed to working with the FDA to bring roxadustat to patients with anemia of CKD in the U.S. as soon as possible, said Enrique Conterno, Chief Executive Officer, FibroGen.

Key Points: 
  • While disappointed with the news today, FibroGen and AstraZeneca are committed to working with the FDA to bring roxadustat to patients with anemia of CKD in the U.S. as soon as possible, said Enrique Conterno, Chief Executive Officer, FibroGen.
  • Roxadustat has been approved in China, Japan and Chile for the treatment of anemia of CKD in both non-dialysis dependent (NDD) and dialysis-dependent (DD) adult patients.
  • Roxadustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor, is the first HIF-PH inhibitor accepted by theFDAfor review for the treatment of anemia of CKD.
  • Several other licensing applications for roxadustat have been submitted by Astellas and AstraZeneca to regulatory authorities across the globe, and are currently in review.

Akebia Presents Results from its PRO2TECT Global Phase 3 Program of Vadadustat for the Treatment of Anemia due to Chronic Kidney Disease in Adult Patients Not on Dialysis During Late-Breaking Session at American Society of Nephrology Kidney Week 2020 Reim

Retrieved on: 
Friday, October 23, 2020

"The PRO2TECT results show that orally administered vadadustat achieved both primary and secondary efficacy endpoints in patients not on dialysis with anemia associated with CKD.

Key Points: 
  • "The PRO2TECT results show that orally administered vadadustat achieved both primary and secondary efficacy endpoints in patients not on dialysis with anemia associated with CKD.
  • Akebia's vadadustat development program also includes INNO2VATE, the global Phase 3 program for the treatment of anemia due to CKD in adult patients on dialysis.
  • Results from this program were presented at ASN Kidney Weekin an oral presentation on October 22, 2020.
  • In Japan, vadadustat is approved as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adult patients.

Akebia Therapeutics to Present Research at NKF 2020 Spring Clinical Meetings Live Virtual Conference

Retrieved on: 
Monday, March 23, 2020

CAMBRIDGE, Mass., March 23, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, today announced that the Company will present three posters at the upcoming National Kidney Foundation (NKF) 2020 Spring Clinical Meetings Live Virtual Conference.

Key Points: 
  • CAMBRIDGE, Mass., March 23, 2020 /PRNewswire/ -- Akebia Therapeutics, Inc. (Nasdaq: AKBA), a biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease, today announced that the Company will present three posters at the upcoming National Kidney Foundation (NKF) 2020 Spring Clinical Meetings Live Virtual Conference.
  • The posters present studies of Akebia's investigational oral HIF-prolyl hydroxylase inhibitor (HIF-PHI), vadadustat, which relates to Nobel Prize-winning science, the hypoxia-inducible factor (HIF) mechanism.
  • Akebia posters on vadadustat, to be presented at the NKF 2020 Spring Clinical Meetings Live Virtual Conference, are now available through the Abstract and ePoster Gallery and through the NKF SCM20 mobile app.
  • Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company focused on the development and commercialization of therapeutics for people living with kidney disease.