Pharmaprojects R&D Pipeline News Feed
Takeda delays EU registration filings for alogliptin
5 Jun 2009
Takeda has announced that it will delay two EU MAA filings for its dipeptidyl peptidase-4 inhibitor alogliptin, following a review of its development strategy. European filings for alogliptin and alogliptin/Actos, a fixed-dose combination of alogliptin with pioglitazone, will be delayed from the 3rd quarter of 2009 to 2012 while an additional long-term clinical trial of alogliptin is conducted in order to provide more robust approval data to the MAA.
The randomized, double-blind Phase III study in 2445 type II diabetics will assess the efficacy and safety of oral alogliptin 12.5 or 25mg compared to glipizide (Glucotrol) in combination with metformin. In previous Phase III trials, the combination significantly improved glycaemic control and measures of insulin resistance and ß-cell function.
Both alogliptin and alogliptin/Actos are currently under review by the US FDA, with alogliptin also awaiting approval in Japan.
