Natalizumab Cleared for MS

Posted August 4th, 2010. Filed under Drugs News

Natalizumab (Tysabri, Biogen Idec/ Elan), a once-monthly IV drug for multiple sclerosis, will be available again under a restricted distribution program. It was pulled from the market last year because of a life-threatening side effect.

Approved in November 2004, the drug was voluntarily withdrawn in February 2005 after two patients in clinical trials died of progressive multifocal leuko-encephalopathy, a rare brain infection. canadian pharmacy generic viagra

This drug is to be used alone in patients who have not responded adequately to, or who cannot tolerate, other MS drugs.

TysabriThe FDA has confirmed three new cases of a rare but potentially lethal brain inflammation linked to natalizumab (Tysabri, Biogen Idec/Elan), a medication that is used for multiple sclerosis (MS) and Crohn’s disease.

There have been 13 reported cases of progressive multifocal leukoencephalopathy (PML) since mid-2006. All of the PML cases are linked to the drug’s use for MS. Natalizumab drags was approved in November 2004 but was withdrawn from the market in 2005 for 18 months because of PML reports. It was reintroduced in July 2006.

Read the rest of this entry »