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New Drug Rituxan Gets FDA Approval

Posted Apr 22 2011 12:00am

On April 19th, the The United States Food and Drug Administration or FDA for short, passed a new drug for the treatment of two vascular conditions, namely Wegners granulomatosis and microscopic polyangiitis.

Rituxan is a drug that is manufactured by IDEC Pharmaceuticals, and has a few other names associated with it including Rituximab and MabThera and while the drug has been talked about a bit, here are a few things that we should all have info about regarding it…

Rituximab was developed by IDEC Pharmaceuticals (formed in 1986 by biotech pioneers Ivor Royston and Howard Birndorf ). [1] Based on its safety and effectiveness in clinical trials , [2] rituximab was approved by the FDA in 1997 for B cell non-Hodgkin lymphoma resistant to other chemotherapy regimens. [3] Rituximab, in combination with CHOP chemotherapy, is now standard therapy in the initial treatment of diffuse large B cell lymphoma and many other B cell lymphomas.[ citation needed ]

It is currently co-marketed by Biogen Idec and Genentech in the U.S. and by Roche in Canada (under the trade name Rituximab) and the European Union and by Chugai Pharmaceuticals and Zenyaku Kogyo in Japan.

Since April 2007 rituximab has also been available from Dr. Reddy’s Laboratories, an Indian-based biogeneric manufacturer. [4]

In 2010 it was approved by the EC for first-line maintenance treatment of follicular lymphoma .

Asfar as uses for the drug there are several, but we are most concerned with Autoimmune Diseases…

Rituximab has been shown to be an effective rheumatoid arthritis treatment in three randomised controlled trials and is now licensed for use in refractory rheumatoid disease. [7] In the United States, it has been FDA-approved for use in combination with methotrexate (MTX) for reducing signs and symptoms in adult patients with moderately- to severely-active rheumatoid arthritis (RA) who have had an inadequate response to one or more anti- TNF-alpha therapies.

There is some evidence for efficacy, but not necessarily safety , in a range of other autoimmune diseases, and rituximab is widely used off-label to treat difficult cases of multiple sclerosis , [8] systemic lupus erythematosus and autoimmune anemias . [9] There are significant concerns about progressive multifocal leukoencephalopathy (PML) infection in SLE patients [10] and other conditions. [9]

Other autoimmune diseases that have been treated with rituximab include autoimmune hemolytic anemia , pure red cell aplasia , idiopathic thrombocytopenic purpura (ITP), [11] [12] Evans syndrome , [13] vasculitis (for example Wegener’s Granulomatosis ), bullous skin disorders (for example pemphigus , pemphigoid ), type 1 diabetes mellitus , Sjogren’s syndrome , and Devic’s disease , [14] and thyroid-associated ophthalmopathy. [15]

A new study from Norway suggests that rituximab (together with methotrexate ) might help patients with chronic fatigue syndrome . [16] A clinical trial is ongoing. [17]

So this drug should help in the treatment of at least two vascular conditions and as you can see from above they are also looing into it’s use in the treatment of chronic fatigue syndrome.

While I’m grateful for any drug that can help in the treatment of any vascular condition, this news is still a long way off from the term ” Cure” for vascular condition.

But, it certainly is a beginning.

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