Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Shire has submitted an application to European regulators seeking approval to market its investigational compound SPD476 for the once-daily treatment of mild-to-moderate ulcerative colitis.
Subscribe to our email newsletter
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.