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Shire files for European approvals of SPD476 for colitis
By Lisa Kerner
Erie, Pa., Feb. 3 - Shire plc said it has submitted Marketing Authorization Applications to European regulatory agencies for SPD476, an investigational compound being studied for the induction and maintenance of clinical and endoscopic remission in patients with active mild to moderate ulcerative colitis.
SPD476 is a novel, high-dose 5-aminosalicylic acid (5-ASA; mesalazine) in a delayed- and extended-release formulation (Multi Matrix System).
The most common adverse events reported in SPD476 phase 3 studies were flatulence, nausea or headaches, occurring in less than 3% of patients.
If approved, SPD476 would offer a once-daily mesalazine treatment for active mild to moderate ulcerative colitis, according to a company news release.
Shire submitted a New Drug Application for SPD476 to the Food and Drug Administration in December and recently filed a similar application with Health Canada.
"Currently there is no once-daily oral treatment for ulcerative colitis so we look forward to offering patients the efficacy and convenience of SPD476," Shire chief executive Matthew Emmens said in the release.
Shire licensed the exclusive rights to develop and commercialize SPD476 in the United States, Canada, Europe (excluding Italy) and the Pacific Rim from Giuliani SpA, the SPD476 formula developer.
Shire is a specialty pharmaceutical company focused on products for the central nervous and the gastrointestinal systems, and human genetic therapies. The company is based in Basingstoke, United Kingdom.
Giuliani SpA is a privately owned specialty pharmaceutical company with its headquarters in Milan, Italy.
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