If approved, SPD476 would offer a once-daily mesalazine treatment for the disorder. Last year, the mesalazine market segment for ulcerative colitis was worth around $1.6 billion.
“The European submissions for SPD476 represent the achievement of another important milestone for Shire,” said Shire chief executive Matthew Emmens. “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 has also recently submitted new drug applications seeking marketing approval for the drug in the US and Canada. The company licensed exclusive rights to the drug in the US, Canada, Europe (excluding Italy) and the Pacific Rim, from Italian company Giuliani SpA.