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(Full text of a statement. Contact details below.)
(BW)(MD-ELAN-CORPORATION)(ELN)(BIIB) Joint FDA Advisory Committee Recommends Approval of TYSABRI(R) for the Treatment of Moderate to Severe Crohn's Disease
GAITHERSBURG, Md.--(BUSINESS WIRE)--July 31, 2007--Elan Corporation, plc (NYSE: ELN) and Biogen Idec (NASDAQ: BIIB) announced today that the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the U.S. Food and Drug Administration (FDA) voted 12 in favor to 3 opposed, with 2 abstaining, to recommend approval of TYSABRI(R) (natalizumab) as a treatment for moderate-to-severe Crohn's disease in patients who have failed or cannot tolerate available therapies.
The recommendation is advisory to the FDA, and the agency is not bound by this recommendation. Elan and Biogen Idec will continue to work closely with the FDA in the weeks ahead with the goal of making TYSABRI available for the treatment of appropriate patients with Crohn's disease. Discussions with the FDA will include adapting the existing TYSABRI risk management plan and addressing any other issues raised during the Committees' deliberations on this new indication.
About TYSABRI(R) (natalizumab)
TYSABRI is a treatment approved for relapsing forms of multiple sclerosis (MS) in the US and relapsing-remitting MS in the European Union. According to data that have been published in the New England Journal of Medicine, after two years, TYSABRI treatment led to a 68% relative reduction (p less than 0.001) in the annualized relapse rate compared to placebo and reduced the relative risk of disability progression by 42-54% (p less than 0.001).
TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Other serious adverse events that have occurred in TYSABRI-treated patients included hypersensitivity reactions (e.g., anaphylaxis), infections, depression and gallstones. Serious opportunistic and other atypical infections have been observed in TYSABRI-treated patients, some of whom were receiving concurrent immunosuppressants. Herpes infections were slightly more common in patients treated with TYSABRI. In MS trials, the incidence and rate of other serious and common adverse events, including the overall incidence and rate of infections, were balanced between treatment groups. Common adverse events reported in TYSABRI-treated patients include headache, fatigue, infusion reactions, urinary tract infections, joint and limb pain, lower respiratory infections, rash, gastroenteritis, abdominal discomfort, vaginitis, and diarrhea.
Source: HighBeam Research, FDA COMMITTEE RECOMMENDS APPROVAL OF TYSABRI TO TREAT CROHN'S DISEASE.