Elan has MS drug filing accepted in US

Biogen Idec and Elan Corporation have announced that the US Food and Drug Administration (FDA) has formally accepted their Biologics License Application (BLA) for Multiple Sclerosis drug Antegren (natalizumab).

In June 2004, the FDA designated natalizumab for priority review and accelerated approval for the treatment of multiple sclerosis (MS). Acceptance of a filing indicates that the FDA has determined that the application is complete and permits a substantive review.

The FDA's review of natalizumab will be based on one-year data from two ongoing Phase III trials.

MS is a chronic disease of the central nervous system that affects approximately 400,000 people in North America and approximately one million people worldwide. It is a disease that affects more women than men, with onset typically between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

Antegren is designed to inhibit the migration of immune cells into tissues where they may cause or maintain inflammation, Elan said today.

Biogen Idec and Elan are collaborating equally on the development of natalizumab in MS, CD, and rheumatoid arthritis (RA).