Buy Inrebic (fedratinib)

The Food and Drug Administration’s (FDA) approval of Inrebic (fedratinib) was based on the results of a clinical trial where 289 patients with myelofibrosis were randomized to receive two different doses (400 mg or 500 mg daily by mouth) of Inrebic (fedratinib) or placebo.

Results

The clinical trial showed that 35 of 96 patients treated with the Inrebic (fedratinib) 400 mg daily dose (the dose recommended in the approved label) experienced a significant therapeutic effect, measured by greater than or equal to a 35% reduction from baseline in spleen volume at the end of cycle 6 (week 24).

As a result of treatment with Inrebic (fedratinib), 36 patients experienced greater than or equal to a 50% reduction in myelofibrosis-related symptoms, such as night sweats, itching, abdominal discomfort, feeling full sooner than normal, pain under ribs on the left side, and bone or muscle pain.

Please refer to the summary of product characteristics below for comprehensive information about the safety and effectiveness of Inrebic (fedratinib) for the approved indication.

References

1. U.S. Food and Drug Administration. FDA approves treatment for patients with rare bone marrow disorder. 16/08/2019 (last update: 16/08/2019), cited on 03/01/2020.

2. Full prescribing information [FDA]: Inrebic (fedratinib) [PDF], Impact Biomedicines, Inc., Aug.2019.