MHRA approval for Astellas’ roxadustat for anaemia of chronic kidney disease

MHRA approval for Astellas’ roxadustat for anaemia of chronic kidney disease

The Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Astellas’ Evrenzo™▼ (roxadustat) for the treatment of adult patients with symptomatic anaemia associated with chronic kidney disease (CKD).

Roxadustat is the first and only hypoxia-inducible factor, prolyl hydroxylase inhibitor (HIF-PHI) licensed for use in Great Britain. The licence was based on results from a comprehensive pivotal Phase III programme comprising of eight multicentre and randomised studies, which involved 9,600 patients worldwide5-10.

Roxadustat activates the body’s natural response to reduced oxygen levels in the blood via inhibition of the HIF-PH pathway. The response involves the regulation of multiple, coordinated processes that improve iron absorption and mobilisation, and increase red cell production, and can therefore assist in the management of anaemia of CKD.

According to the World Health Organisation (WHO), around 20% of people living with diagnosed CKD suffer from anaemia2,3. Additionally, patients with CKD that also suffer from anaemia have impaired health-related quality of life (HRQoL) compared to patients without the added complication of anaemia4.

Jonathan Barratt, Ph.D., FRCP, Consultant Nephrologist and the Mayer Professor of Renal Medicine at the University of Leicester, United Kingdom said: “Anaemia is a significant and early complication of CKD that occurs with greater frequency and impact as CKD worsens, impacting patients’ day-to-day living, self-care and mobility. This licence represents a step forward in providing patients with an alternative option to manage anaemia symptoms and maintain target haemoglobin levels to minimise the impact on their quality of life.”

Dr. Timir Patel, Medical Director, Astellas UK and Ireland said: “This is an excellent demonstration of how a ground-breaking, Nobel prize winning, scientific discovery can inform and pave the way for innovative medicines that can benefit patients. Through its novel mechanism of action, roxadustat offers physicians an orally administered option to tackle anaemia of CKD, a complex and multi-faceted disease that can be hugely debilitating.”

References

[1] The Nobel Prize. The Nobel Prize in Physiology or Medicine 2019 [Accessed August 2020]. Available from: https://www.nobelprize.org/prizes/medicine/2019/press-release/.

[2] Nephrology ISo. Chronic kidney disease. Global kidney health atlas 2019 [Accessed August 2021]. Available from: https://www.theisn.org/wp-content/uploads/2021/05/GKHAtlas_2019_WebFIle-1.pdf.

[3] Dmitrieva O, de Lusignan S, Macdougall IC, Gallagher H, Tomson C, Harris K, et al. Association of anaemia in primary care patients with chronic kidney disease: cross sectional study of quality improvement in chronic kidney disease (QICKD) trial data. BMC Nephrol. 2013;14:24.

[4] Eriksson D, Goldsmith D, Teitsson S, Jackson J, van Nooten F. Cross-sectional survey in CKD patients across Europe describing the association between quality of life and anaemia. BMC Nephrol. 2016;17(1):97.

[5] Clinicaltrials.Gov. Roxadustat in the Treatment of Anemia in End Stage Renal Disease (ESRD) Patients on Stable Dialysis (Pyrenees). NCT02278341.  [Accessed August 2021]. Available from: https://clinicaltrials.gov/ct2/show/NCT02278341.

[6] Shutov E, Sułowicz W, Esposito C, Tataradze A, Andric B, Reusch M, et al. Roxadustat for the treatment of anemia in chronic kidney disease patients not on dialysis: a phase 3, randomized, double-blind, placebo-controlled study (ALPS). Nephrol Dial Transplant. 2021.

[7] Coyne DW, Roger SD, Shin SK, Kim SG, Cadena AA, Moustafa MA, et al. Roxadustat for CKD-related Anemia in Non-dialysis Patients. Kidney Int Rep. 2021;6(3):624-35.

[8] Provenzano R, Shutov E, Eremeeva L, Korneyeva S, Poole L, Saha G, et al. Roxadustat for anemia in patients with end-stage renal disease incident to dialysis. Nephrol Dial Transplant. 2021.

[9] Fishbane S, El-Shahawy MA, Pecoits-Filho R, Van BP, Houser MT, Frison L, et al. Roxadustat for Treating Anemia in Patients with CKD Not on Dialysis: Results from a Randomized Phase 3 Study. J Am Soc Nephrol. 2021;32(3):737-55.

]10] Barratt J, Andric B, Tataradze A, Schömig M, Reusch M, Valluri U, et al. Roxadustat for the treatment of anaemia in chronic kidney disease patients not on dialysis: a phase 3, randomised, open-label, active-controlled study (DOLOMITES). Nephrol Dial Transplant. 2021.