FDA Approves New Rituximab Biosimilar & Anakinra to Treat a Rare Disease

The U.S. Food & Drug Administration (FDA) approved anakinra to treat a rare autoinflammatory disease, deficiency of interleukin (IL) 1 receptor antagonist (DIRA). The administration also approved a new rituximab biosimilar, Riabni, for multiple indications.

Anakinra Approved for DIRA
In late December 2020, the FDA approved anakinra (Kineret) to treat deficiency of interleukin (IL) 1 receptor antagonist (DIRA). DIRA is a rare, autoinflammatory disease that occurs during the first weeks of life and is caused by a genetic mutation in the IL1RN gene that encodes for this specific receptor. Patients with this deficiency get unopposed IL-1 signaling that leads to a life-threatening systemic inflammatory response, affecting the bones and skin.¹

In November 2001, the FDA initially approved anakinra to treat the signs and symptoms of moderate to severe active rheumatoid arthritis in adults for whom one or more disease-modifying anti-rheumatic drugs were ineffective.² The treatment was subsequently approved for treating neonatal-onset multi-system inflammatory disease.³

Background: Research supporting this latest FDA approval included patients (N=9) aged 1 month to 9 years old who were evaluated in a long-term natural history study and treated for up to 10 years. These patients received a range of anakinra doses, from 1 mg/kg/day up to 7.5 mg/kg per day.

All study patients attained inflammatory remission, defined as a C-reactive protein level of less than or equal to 5 mg/L. No inflammatory bone disease or pustulosis, and no concomitant glucocorticoid use were reported. The most common adverse events were fever, flu-like illness, gastroenteritis, rash and upper respiratory infection.

During this study, anakinra’s safety profile was consistent with that seen when treating neonatal-onset multi-system inflammatory disease. No new safety signals were identified.

FDA Approves Rituximab Biosimilar
On Dec. 17, 2020, the FDA approved Riabni (rituximab-arrx), which is biosimilar to Rituxan (rituximab).⁴ This agent is approved to treat adults with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis (Wegener’s granulomatosis) and microscopic polyangiitis.

Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.

References

1. Swedish Orphan Biovitrum AB. News release: FDA approves Kineret (anakinra) for the treatment of deficiency of IL-1 receptor antagonist (DIRA). 2020 Dec 22.
2. U.S. Food & Drug Administration. Product approval letter: Kineret. 2001 Nov 14.
3. Swedish Orphan Biovitrum AB. Package labeling Kineret (anakinra). 2020 Dec.
4.      Amgen. News release: FDA approves Amgen’s Riabni (rituximab-arrx), a biosimilar to Rituxan (rituximab). 2020 Dec 17.