Elan and partner submit Tysabri license application

Biogen Idec and Elan announced today that they have submitted a supplemental Biologics License Application (sBLA) for multiple-sclerosis drug Tysabri to the US Food and Drug Administration (FDA).

The sBLA includes integrated safety assessment of patients treated with Tysabri in clinical trials and a revised label and risk-management plan.

The companies have requested priority review status for the sBLA which, if granted, would result in action by the FDA approximately six months from the submission date, rather than 10 months for a standard review.

Biogen Idec and Elan will submit a similar data package to the European Medicines Agency (EMEA).

Biogen Idec’s managing director Burt Adelman said: “We are grateful to the MS community for their patience and support over the last several months while we've conducted an extensive safety evaluation of Tysabri in collaboration with leading experts.

“We look forward to working with regulatory authorities during the review process, and ultimately, we hope to provide Tysabri to people living with MS, a disease with significant unmet need.”