Rituxan gets FDA approval for treatment of Wegener's Granulomatosis and Microscopic Polyangiitis

Rituxan gets FDA approval for treatment of Wegener's Granulomatosis and Microscopic Polyangiitis

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(Best Syndication News) - Two rare disorders that cause vasculitis, Wegener’s granulomatosis (WG) and microscopic polyangiitis (MPA), have a new treatment called Rituxan (rituximab) that was approved by the FDA today. The Rituxan along with glucocorticoids (steroids) is the treatment that was approved for the treatment of these rare disorders. Rituxan is the first approved therapy that is used to treat these diseases. Rituxan is made by Genentech, who is part of the Roche Group. Rituxan has been approved since 1997 to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.

Rituxan uses biotechnology methods to make an antibody that reduces the amount 'B cells' which are specific immune cells. There was a single controlled trial study of 197 patients that had either WG or MPA. The researchers randomly assigned the patient Rituxan plus glucocorticoids once a week for four weeks or they gave the patient an oral cyclophosphamide plus glucocorticoids daily. The study duration at six months showed the patients that had the Rituxan with the glucocorticoids had 64 percent of the patients have complete remission. The cyclosphosphamide and glucocorticoids patients had 53 percent achieve complete remission.

The study did not investigate to see if re-treatment with Rituxan was safe. So they would need more studies to ensure if repeat treatments are safe for WG and MPA patients.

Rituxan has a Boxed Warning because of infusion reaction that can occur during and up to 24 hours after the therapy. Other Boxed Warnings include rashes and sores in the skin and mouth, and a progressive multifocal leukoencephalopathy which is a brain infection that is usually fatal. Rituxan was not recommended for patients that have a severe or active infection.

Common side effects of Rituxan include infection, nausea, diarrhea, headache, muscle spasms, and anemia.

BY: N Wilson



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