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Astellas receives positive CHMP opinion for symptomatic anaemia drug

pharmafile | June 28, 2021 | News story | Sales and Marketing Astellas, CKD, anaemia 

Astellas and FibroGen have announced that the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion relating to the use of roxadustat for the treatment of anaemia symptoms in patients with chronic kidney disease (CKD).

The companies have said in a release that they now intend to submit a marketing authorisation application in the UK with the MHRA via the European Commission Decision Reliance Procedure by the end of June 2021.

If approved by the MHRA, roxadustat will be the first orally administered hypoxia-inducible factor (HIF) prolyl hydroxylase inhibitor (PHI) available in the UK.

Roxadustat increases haemoglobin (Hb) levels through a different mechanism of action compared to erythropoiesis-stimulating agents. As a HIF-PHI, roxadustat activates the body’s natural response to reduced oxygen levels in the blood. This response involves the regulation of multiple, coordinated processes that lead to the correction of anaemia.

Around 20% of people living with CKD in the United Kingdom also suffer from anaemia. Anaemia associated with CKD is connected with significant impairment in quality of life and progression to adverse cardiovascular and renal outcomes.

Dr Timir Patel, said: “Anaemia of CKD remains an under recognised and undertreated condition that can be highly debilitating for people living with it. We are pleased to receive a positive opinion from the CHMP and look forward to assessment by the MHRA. If approved, roxadustat will provide a new treatment option for this group of patients in an area that has not seen a novel class of drugs approved since the early 2000s.”

The positive CHMP opinion is based on the results from a Phase III clinical trial programme comprising of eight multicentre randomised studies, involving over 9,600 patients worldwide. The safety profile observed in the roxadustat development program is reflective of the CKD populations studied and comparable to ESAs.

Kat Jenkins

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