Takeda's alogliptin delayed, as firm starts new outcomes study at FDA request

Leading Japanese drugmaker Takeda and its US subsidiary have received notification that the US Food and Drug Administration has agreed to the study design for a cardiovascular outcomes trial titled EXAMINE (EXamination of CArdiovascular OutcoMes: AlogliptIN versus Standard of CarE in Patients with type 2 Diabetes Mellitus and Acute Coronary Syndrome) for alogliptin, a selective dipeptidyl peptidase IV inhibitor under investigation for the treatment of type 2 diabetes as an adjunct to diet and exercise. This means that regulatory approval for the drug will be delayed for around two years, and leaves the company exposed to US patent expiry in 2011 for its blockbuster diabetes drug Actos (pioglitazone),

The alogliptin New Drug Application (NDA) was submitted in December 2007, and in the complete response for alogliptin dated June 26, 2009, the FDA requested an additional CV safety trial that satisfies the criteria outlined in the December 2008 'Guidance for Industry: Diabetes Mellitus - Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes.' The EXAMINE study is designed to comply with this Guidance.

'Takeda received FDA agreement to the design of the CV study and we are pleased to move forward with the study and collecting additional safety data so that the FDA can continue the review of the alogliptin NDA,' said Nancy Joseph-Ridge, general manager, Pharmaceutical Development Division. 'We are committed to conducting this study to satisfy the CV safety requirements, leading to the enhancement of the product profile of alogliptin. While this trial is dependent on the occurrence of CV events, at this point we anticipate that we will be able to submit interim results to the FDA approximately two years after the study begins that will meet the FDA Guidance criteria for drug approval,' she added.