Shire submits UC NDA on Mesavance
UK drugmaker Shire says it has submitted a New Drug Application to the US Food and Drug Administration for Mesavance (SPD476), an investigational compound being studied for the induction of clinical and endoscopic remission in patients with active, mild-to-moderate ulcerative colitis. If approved, the drug would be the first available once-daily mesalamine treatment for this condition.
The NDA represents the fourth new product submission in 2005 for the UK firm, which also plans to submit a Marketing Authorization Application to the European Medicines Agency in first-quarter 2006.
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