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Takeda's delayed diabetes drug alogliptin gets European filing

Drug submitted to EMA for review with extra cardiovascular safety data

The European Medicines Agency (EMA) has accepted Takeda's type 2 diabetes treatment alogliptin for review, three years after the Japan-based pharma company originally intended to file the drug.

The European marketing authorisation application for alogliptin was postponed however after the drug failed to be approved in the US, with the Food and Drug Administration (FDA) requesting more clinical data regarding the drug's cardiovascular safety.

Since then, Takeda has launched an additional safety trial called EXAMINE as part of its series of studies into the drug.

Although final data from this trial isn't expected until 2015, preliminary results are being used to support alogliptin's marketing application in Europe.

“The acceptance of the alogliptin MAA submission is a critical milestone for Takeda as we continue investigating and expanding our therapeutic offerings for people with type 2 diabetes,” said Dr Stuart Dollow, managing director, Takeda Global Research & Development Centre (Europe).

“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.”

The drug is a selective dipeptidyl peptidase IV inhibitor (DPP-IV) and being investigated as an adjunct therapy to diet and exercise.

It is developed to work by reducing the speed at which the incretin hormones GLP-1 and GIP become inactive.

This then leads to an increased amount of active incretins that enable the pancreas to secrete insulin, leading to better management of blood glucose levels as the insulin metabolises sugar.

Other DPP-IV inhibitors already available include Merck & Co's Januvia (sitagliptin), Bristol-Myers Squibb/AstraZeneca's Onglyza (saxagliptin), Eli Lilly and Boehringer Ingelheim's Trajenta (linagliptin) and Novartis' Galvus (vildagliptin).

Takeda also filed alogliptin in the US as part of a fixed dose combination with metformin in November, 2011.

The drug has been available in Japan since 2010 where it is marketed as Nesina.

• Discover more about the cardiovascular safety profile of diabetes treatments

25th May 2012

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