Elan said today its application for approval of multiple sclerosis drug Antegren had been formally accepted for review by the US Food and Drug Administration.
Antegren, which Elan has developed with US partner Biogen Idec, represents a new approach in the treatment of multiple sclerosis and is expected to eventually generate annual sales of more than $1 billion.
The US regulator will now review the drug before deciding if it can go on sale. Antegren won priority status from the FDA last month, which means the medicine could be approved within six months rather than the standard 10 months review time.
The much-vaunted drug has given Elan a major boost after its stock collapsed by more than 90 per cent in 2002 on fears about its liquidity.
Antegren is also being developed as a treatment for the bowel disorder Crohn's disease and rheumatoid arthritis. It is expected to hit the market by early 2005, some 18 months ahead of the original schedule.
Multiple sclerosis is a disease of the central nervous system which affects about a million people worldwide.