(Weston-Based) and Genentech (California) won an approval from U.S. Food and Drug Administration to develop a drug as a part of a new treatment for Wegener's Granulomatosis and Microscopic Polyangiitis diseases. These are very rare and fatal diseases.
The drug Rituxan (FDA approved) is used to treat rheumatoid arthritis, chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. This drug can now also be used in combination with corticosteroids - to treat two other diseases - Wegener’s Granulomatosis and Microscopic Polyangiitis. These diseases impact small blood vessels of the lungs, kidneys, sinuses and other organs. There are many people in U.S. afflicted with these diseases.
Rituxan can be used as an alternate treatment for the CYC chemotherapy treatment for the diseases. The CYC chemotherapy and Rituxan have shown similar results at six months. Based on study and results FDA has approved Rituxan to be used for the same.
The FDA had alerted in 2006 informing that two patients taking the drug (Rituxan) to treat systemic lupus erthematosus were not approved to use the drug. Both the patients had died due to an infection of the central nervous system known as Progressive multifocal leukoencephalopathy. Treating Systemic lupus erythematosus with the drug is not appoved use of the drug.
In 2010, a man sued Biogen and Genentech, as he suffered an infection which paralyzed him. He said that Rituxan had made him more prone to such infections. He was under the medication for thrombotic thromboctopenic purpura, a blood disease that is very rarely found. Rituxan is not an approved drug for the same.
The drug Rituxan (FDA approved) is used to treat rheumatoid arthritis, chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. This drug can now also be used in combination with corticosteroids - to treat two other diseases - Wegener’s Granulomatosis and Microscopic Polyangiitis. These diseases impact small blood vessels of the lungs, kidneys, sinuses and other organs. There are many people in U.S. afflicted with these diseases.
Rituxan can be used as an alternate treatment for the CYC chemotherapy treatment for the diseases. The CYC chemotherapy and Rituxan have shown similar results at six months. Based on study and results FDA has approved Rituxan to be used for the same.
The FDA had alerted in 2006 informing that two patients taking the drug (Rituxan) to treat systemic lupus erthematosus were not approved to use the drug. Both the patients had died due to an infection of the central nervous system known as Progressive multifocal leukoencephalopathy. Treating Systemic lupus erythematosus with the drug is not appoved use of the drug.
In 2010, a man sued Biogen and Genentech, as he suffered an infection which paralyzed him. He said that Rituxan had made him more prone to such infections. He was under the medication for thrombotic thromboctopenic purpura, a blood disease that is very rarely found. Rituxan is not an approved drug for the same.
No comments:
Post a Comment