Tysabri (natalizumab): Approved by FDA For Moderate-to-Severe Crohn's Disease

Filed in archive Digestive Disorders , FDA Approvals , Treatment on January 15, 2008

Previously approved for use in the treatment of some forms of multiple sclerosis (MS) - Tysabri (natalizumab) - is now approved by the FDA for the treatment of moderate-to-severe Crohn's disease in patients with evidence of inflammation (not fully respondent or tolerant to conventional therapies).

Crohn's disease patients using the drug must be enrolled in a special restricted distribution program called the Crohn's Disease-Tysabri Outreach Unified Commitment to Health (CD TOUCH) Prescribing Program.

The approval is consistent with an agency advisory committee recommendation to approve Tysabri for use in Crohn's patients. Tysabri was approved by the FDA in June 2006 to treat relapsing forms of multiple sclerosis.

Of unknown cause, Chron's disease is a chronic, inflammatory bowel disease that affects both men and women; with no cure and suffered by more than 1 million people worldwide.

Manufactured by Biogen Idec (Cambridge, Massachusetts) and Elan (Dublin, Ireland), Tysabri carries a boxed warning for progressive multifocal leukoencephalopathy (PML) - an opportunistic viral infection affecting the brain which can lead to death or severe disability.

Find more details from the FDA News.

[Photo Credit: NY Times]