Regulatory Affairs

Biogen, Elan seek FDA, EMA approvals for first-line Tysabri use in MS

PBR Staff Writer Published 17 January 2013

Biogen Idec and Elan are seeking approvals from the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) for first-line use of Tysabri (natalizumab) in anti-JCV antibody negative patients with multiple sclerosis (MS).

The submissions for the approval are supported by risk stratification data and a risk algorithm, which enables physicians and patients with MS to make informed decisions when considering treatment with TYSABRI.

During the previous studies, TYSABRI has shown to slow disability progression by 42 - 54% and reduce annualized relapse rates by 68%.

Biogen Idec chief medical officer and development sciences senior vice president Alfred Sandrock said the company's anti-JCV antibody test, STRATIFY JCV, helps to determine the appropriate patients for TYSABRI and the data collected to date supports its recent filing for first-line use.

"Many appropriate patients are already benefiting from TYSABRI. A first line approval would allow people with MS access to a highly efficacious treatment earlier in the course of the disease, potentially leading to better outcomes," Sandrock added.

In the EU, TYSABRI is approved for treating highly active relapsing-remitting MS (RRMS) in adult patients who have failed to respond to beta interferons or have rapidly evolving, severe RRMS.