The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on the use of Rienso injection to treat iron-deficiency anaemia in patients with chronic kidney disease (CKD).
The Committee has recommended granting marketing authorisation for the treatment as a 30mg/ml solution for intravenous injection.
The diagnosis of iron deficiency must be based on
appropriate laboratory tests.
The applicant for marketing authorisation of this medicinal product is Takeda Global Research and Development Centre (Europe) Ltd.
The active substance of Rienso is Ferumoxytol, a colloidal iron-carbohydrate complex. Upon release from the complex, the iron either enters the intracellular storage iron pool (e.g., ferritin) or is
transferred to plasma transferrin for transport to erythroid precursor cells for incorporation into haemoglobin.
The benefits with Rienso are its ability to increase haemoglobin levels.
The most common side effects are diarrhoea, nausea, constipation, headache, dizziness and hypotension.
A pharmacovigilance plan for Rienso will be implemented as part of the marketing authorisation.