If approved, Mesavance would be the first available once-daily mesalamine treatment for active, mild-to-moderate ulcerative colitis.
“The timely filing of our Mesavance NDA represents the fourth new product submission in 2005 for Shire and our partners,” said Shire chief executive Matthew Emmens. “We are proud of that achievement and we look forward to offering the advantages of once-daily Mesavance to patients suffering from ulcerative colitis.”
The submission of a Marketing Authorisation Application for Mesavance with the European Medicines Agency is planned for first quarter 2006.
Shire licensed the exclusive right to develop and commercialise Mesavance in the US, Canada, Europe (excluding Italy) and the Pacific Rim from Giuliani. Giuliani retains the development and commercialization rights to the drug in Italy.