UK pharmaceutical group Shire has filed its Mesavance (mesalamine) with the US Food and Drug Administration, seeking the all clear to market the agent for the treatment of ulcerative colitis.
If regulators give the product a green light, it will become the first available once-daily mesalamine treatment for active, mild-to-moderate ulcerative colitis, the company noted. Submission to the European Medicines Agency is scheduled for the first quarter of 2006.
Shire will be hoping that the drug, if approved, will help reduce its reliance on its hugely successful attention-deficit hyperactivity disorder drug, Adderall (mixed amphetamine salts), sales of which jumped 18% to $165.9 million in the third quarter.
In line with this strategy, chief executive Matthew Emmens claimed last month that the firm is aiming to launch six drugs in Europe and the USA by 2006, which should substantially boost sales in near future.