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Amgen’s Riabni combination granted FDA approval for rheumatoid arthritis

Rheumatoid arthritis is a long-term condition that causes painful swelling and stiffness in the joints


Amgen’s Riabni (rituximab-arrx), in combination with methotrexate, has been approved by the US Food and Drug Administration (FDA) for adults with moderate to severely active rheumatoid arthritis (RA).

RA is a long-term condition that causes intense pain, stiffness and swelling in the joints, with the condition typically affecting the hands, wrists and feet. The combination of Riabni, a biosimilar for Rituxan, with methotrexate is specifically for adult RA patients who have had one or more unsuccessful prior treatments.

Patients living with RA experience flare-ups or flares, where their symptoms can become worse. Although these instances can be difficult to predict, with treatment it is possible to decrease the occurrence of flares and prevent or reduce permanent damage to the joints.

Riabni is a cytolytic antibody that was proven to be highly similar to Rituxan (rituximab) in the randomised, double-blind study assessing Riabni versus rituximab in patients with moderate to severe RA, showing no clinically significant differences in safety or efficacy based on comparative analytical, non-clinical and clinical data.

"The approval of Riabni is an important advancement for adults living with moderate to severe rheumatoid arthritis, a chronic inflammatory joint disease, who now have access to a proven and affordable treatment option," said Murdo Gordon, executive vice president of global commercial operations at Amgen.

Amgen’s treatment has already been approved for use in adult patients with non-Hodgkin's lymphoma (NHL), chronic lymphocytic leukaemia (CLL), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

Amgen currently has 11 biosimilars in its portfolio, which includes potential treatments for cancer and chronic inflammatory diseases. At present, there are five biosimilars approved in the US, while three have been approved in the EU in Amgen's portfolio.

Riabni is not currently indicated for use as a treatment for children diagnosed with mature B-cell non-Hodgkin's lymphoma, mature B-cell acute leukaemia, MPA or GPA. It is also not indicated for use in adult patients with moderate to severe pemphigus vulgaris, for which Rituxan has received orphan status.

Article by
Fleur Jeffries

7th June 2022

From: Research, Regulatory, Healthcare



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