Tysabri natalizumab regulatory update

Elan withdrew an application in the EU to expand the label of Tysabri natalizumab to include first-line treatment of relapsing-remitting multiple sclerosis (RRMS) that is not highly active in patients who are anti-JC virus (JCV) antibody-negative. According to EMA's CHMP, the company withdrew the application because "the additional data it had to address the CHMP's questions were still provisional." The committee said it was of the provisional opinion at the time of withdrawal that Tysabri could not be approved for the indication based on a risk of over-treating patients with benign forms of MS. ...