Genentech, Biogen Idec seek new FDA approval for Rituxan - Triangle Business Journal:

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Genentech, of South San Francisco, and Mass.-based Biogen Idec (NASDAQ: said they will request a priorityh review, which could result in an FDA decisiom withinsix months. Rituxan, a therapeutic antibodyh already approved for a typeof non-Hodgkin’se lymphoma and for rheumatoid registered sales of $2.6 billiom last year. That was 13 percent higheer thanin 2007. Chronic lymphocytic leukemia which occurs when too many abnormal white blood cells develolp in the blood and bone making it difficult for normal white blooc cells to fightinfection – is the most commo n type of adult leukemia. CLL accounts for one-third of all leukemia s in theUnited States. There is no cure for CLL.
Two clinical studies, which the companies said were two of the largesgt global phase III trials conductedc inCLL patients, showed that Rituxan plus standard chemotherapy allowedd patients to live about 10 monthds without the cancer advancing. That is compared to those patient s in the trials who received chemotherapy Nearly 1,500 patients were involvexd in the trials. “We believe the data supporf the potential role of Rituxan as both an initialand second-line treatment for CLL, and look forwardr to working with the FDA during the reviews period,” said Dr. Hal Barron, Genentech’as chief medical officer and executive vice presideng ofglobal development.
Rituxan works by binding to a particular CD20, that is found on the surfac of malignant cells as well asnormakl B-cells. It helps to kill the marked CD20 positive The drug’s approval for non-Hodgkin’s lymphoma came in Novemberr 1997 and for rheumatoid arthritis in February 2006. Genentechg and Biogen Idec co-market Rituxan in the Unitedd States. Chugai and Zenyaku Kogy o Co. Ltd. market Rituxan in Japan and Roche, whichg in March bought the 44 percent of Genentech thatit didn’t already own for $47 billion, markets the drug in the rest of the Biogen Idec employs more than 850 people at its manufacturinhg facility in Research Triangle Park.