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Wednesday, March 16, 2011

Benlysta belimumab human monoclonal antibodies treat lupus approved US FDA

Benlysta (belimumab) the human monoclonal antibodies to treat lupus are approved by US FDA

The U S FDA has now approved a first drug exclusively for treatment of lupus since last 56 years. Earlier only two drugs approved for lupus were asprin in 1948 and in 1955 corticosteroids and Plaquenil (hydroxychloroquine).
         There was very much limitation of the therapy so far available, but with the newly approved drug to treat lupus (systemic lupus erythematosus), patients suffering from the disease may get better quality life. The brand name of this drug is Benlysta which contains belimumab which are nothing but the human monoclonal antibodies as the active ingredient. Since so many years the disease lupus would be treated by conventional therapy of corticosteroids and immunosuppressant drugs including the antimalerial drugs like Plaquenil (hydroxychloroquine) and nonsteroidal antiinflamatory drugs aspirin and cyclophosphamide which has its own limitations.
         Benlysta (belimumab) will be now used to treat active autoantibody-positive lupus (systemic lupus erythematosus) by direct injection in to systemic circulation through intravenous infusion.

Information about Lupus
Lupus is an autoimmune disease, which attack normal tissue cells in body producing a state of inflammation and tissue damage in the affected part, type III hypersensitivity reactions are produced as the result of these immune reactions. lupus (systemic lupus erythematosus) SLE can affect organs like liver, kidneys, nervous system (brain) and heart, joints and skin, lungs and blood vessels often producing flairs, the common lupus produce swelling in joints with sever pain, chest pain, hair loss and fatigue, light sensitivity and fever, swelling in lymph nodes. Lupus (systemic lupus erythematosus) SLE may develop in to fatal stage if not treated. It is found that lupus (systemic lupus erythematosus) SLE occurs mainly in women in the age of 15 to 35.
The current treatment for lupus (systemic lupus erythematosus) would be providing symptomatic relief from symptoms and with immunosupresant drugs and with cyclophosphamide, corticosteroids , the treatment with cyclophosphamide has its own cytotoxic drawbacks, therefore with the availability of Benlysta (belimumab) will provide a better option for treatment for lupus.

Information about Benlysta (belimumab) and its mode of action:
Benlysta (belimumab) are human monoclonal antibodies which inhibits B-lymphocyte stimulator (BLyS), a cytokine and the tumor necrosis factor (TNF) which is responsible for activation of B cells which intern are responsible for production of autoimmune response which is responsible disease lupus (systemic lupus erythematosus ). Inhibition of B-lymphocyte stimulator (BLyS) also leads to reduction in number of abnormal B cells which are responsible for lupus. Belimumab is also being studied for its beneficial effect on other numerous auto immune diseases.

Clinical studies of Benlysta (belimumab)
In two clinical studies carried out on 1,684 subjects with lupus it was found that the treatment with Benlysta (belimumab) and standard therapy with cyclophosphamide was safe and effective as compared to placebo and standard therapy it was also observed that there is a reduced likelihood of severe flares in some patients, in some patients required dose of steroid was reduced as well.
        The study excluded patients with kidney or central nervous system involvement and those received prior B-cell targeted therapies like intravenous cyclophosphamide states the press release published by US FDA. The sponsors of clinical study will be conducting further clinical study to determine the effectiveness of Benlysta (belimumab) in African American patients and patients with African heritage which were in less number too to ascertain the effect, as in the initial study these patients did not responded to Benlysta (belimumab).
         The drug Benlysta (belimumab) ,ust not be administered along with any live vaccine. The Benlysta (belimumab) will be provided with a medication guide for patients and healthcare professionals information about the risks associated with Benlysta (belimumab).

         Common side effects observed in clinical trial are fever (pyrexia) and nausea, diarrhea and infusion reactions, there for a pre-treatment with antihistamic drug is recommended.Benlysta (belimumab) is developed by Human Genome Sciences Inc., based in Rockville, Md., it is been co-marketed by GlaxoSmithKline of Philadelphia in US.


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