Takeda’s new diabetes drug accepted for European review

Takeda has announced that the European Medicines Agency (EMA) has accepted its submission of a marketing authorisation application for the diabetes drug alogliptin.

The regulator is to assess the selective dipeptidyl peptidase IV inhibitor as a treatment for type 2 diabetes, based on data from clinical trials that underlines the potential safety and efficacy benefits of the drug.

Alogliptin has so far been studied among more than 11,000 patients, who received treatment for up to four years and experienced clinically and statistically significant reductions in haemoglobin A1c levels.

It was utilised as an adjunct to diet and exercise as a once-daily monotherapy and as an add-on therapy to several other classes of anti-diabetic medications, including metformin, thiazolidinediones, insulin and sulfonylureas.

Dr Stuart Dollow, managing director at Takeda's global research and development centre, said: "As type 2 diabetes is an increasing global issue, our commitment includes expanding across the globe to reach a wider patient population who could benefit from new treatments."

Last month, Takeda received a recommendation from the EMA's Committee for Medicinal Products for Human Use for approval of Rienso, its treatment of iron deficiency anaemia in adult chronic kidney disease patients.