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Human medicines European public assessment report (EPAR): Inrebic, fedratinib, Date of authorisation: 08/02/2021, Revision: 5, Status: Authorised

In 2 main studies in patients with myelofibrosis, Inrebic was effective at reducing the size of patients’ spleen.

In the first study, in patients with myelofibrosis who had not been treated with a JAK inhibitor before, 36% of patients (35 out of 97) given Inrebic had at least a 35% reduction in spleen size measured by a scan, compared with 1% (1 out of 96) of patients who received placebo. In this study, 40% of patients (36 out of 89) given Inrebic had at least 50% reduction in symptoms, measured using a myelofibrosis symptom rating scale, compared with 9% (7 out of 81) of patients who received placebo.

A second study involved patients with myelofibrosis who had already been treated with the JAK inhibitor ruxolitinib; for most of them, ruxolitinib treatment had not worked or could not be continued due to side effects, or the disease had come back. In this study, about 23% of patients (22 out of 97) receiving Inrebic 400 mg once daily had at least 35% reduction in spleen size.