Mesalamine fails PhIII and Shire pulls out of diverticulitis
This article was originally published in Scrip
Executive Summary
Shire has been thwarted in its plan to expand use of its oral delayed-release mesalamine product, Lialda (sold as Mezavant in Europe), as top-line data showed that one of two Phase III studies (PREVENT2) of the active ingredient missed its primary, composite endpoint for recurrence of diverticulitis over two years, and its key secondary endpoint too.