Horizon scanning:Natalizumab (Tysabri) filed for approval in EU and US for first-line use in multiple sclerosis
Source: Reuters Health News
Area: News
Natalizumab (Tysabri) has been filed for approval in the EU and US for the first-line treatment of relapsing multiple sclerosis in patients who have tested negative for antibodies to the JC virus.
Use of this drug has been restricted due to its association with progressive multifocal leukoencephalopathy (PML), which is caused by the JC virus. There is now a test for the virus to predict if patients are at risk of developing PML, which Biogen and Elan hope will open the possibility that natalizumab could be used more widely and at an earlier stage of treatment. (Source: NeLM - News)
Source: NeLM - News - January 17, 2013 Category: Drugs & Pharmacology Source Type: news
Biogen Idec and Elan Submit Applications for First-Line Use of TYSABRI in Anti-JCV Antibody Negative Patients with MS
Marketing Applications Supported by Risk Stratification Data
WESTON, Mass. & DUBLIN--(Healthcare Sales & Marketing Network)--Today Biogen Idec (BIIB) and Elan Corporation, plc (ELN) announced that they have submitted applications to the U.S. Food and Dr... Biopharmaceuticals, NeurologyElan Corp, Biogen Idec, TYSABRI, natalizumab, multiple sclerosis, JC virus (Source: HSMN NewsFeed)
Source: HSMN NewsFeed - January 16, 2013 Category: Pharmaceuticals Source Type: news
Biogen, Elan seek okay for first-line Tysabri use in MS
LONDON (Reuters) - Biogen Idec and Elan have filed for approval to sell their drug Tysabri as a first-line treatment for multiple sclerosis, a move that could boost sales of the drug. (Source: Reuters: Health)
Source: Reuters: Health - January 16, 2013 Category: Consumer Health News Tags: healthNews Source Type: news
Application for Tysabri as first line treatment
Biogen and Elan, the manufacturers of natalizumab (Tysabri), have applied to the EMA (for Europe) and FDA (for America) to expand the licence for the drug to include people with relapsing remitting MS who do not have antibodies to the JC virus.
Biogen press release
Natalizumab (Tysabri) - A to Z of MS (Source: Multiple Sclerosis Trust)
Source: Multiple Sclerosis Trust - January 16, 2013 Category: Neurology Source Type: news
