Tysabri (natalizumab) - Jun 5, 2006
Audience: Neurological and other healthcare professionals, patients[UPDATE 07/21/2006] Dear Healthcare Provider Letter issued.
[Posted 06/05/2006] FDA notified healthcare professionals of the resumed marketing, with a special restricted distribution program of Tysabri (natalizumab), a monoclonal antibody for the treatment of patients with relapsing forms of multiple sclerosis. Tysabri was initially approved by the FDA in November 2004, but was withdrawn by the manufacturer in February 2005 after three patients in the drug’s clinical trials developed progressive multifocal leukoencephalopathy (PML), a serious viral infection of the brain. Tysabri will be available only through the Risk Management Plan, called the TOUCH Prescribing Program. In order to receive Tysabri, patients must talk to their doctor and understand the risks and benefits of Tysabri and agree to all of the instructions in the TOUCH Prescribing Program.
[July 2006 - Letter - Biogen Idec/Elan]
[June 05, 2006 - FDA]