EMA Accepts Takeda’s Diabetes Medication, Alogliptin, for Review

Takeda Pharmaceutical announced today that the European Medicines Agency (EMA) has agreed to review their type 2 diabetes treatment, alogliptin, a month after receiving a negative response for the therapy from the US FDA (Food and Drug Administration).

The Japanese drug maker received confirmation of the acceptance of the proposal of a marketing authorisation application from the European Medicines Agency for alogliptin, a selective dipeptidyl peptidase IV (DPP-4) inhibitor.

The filing is based on clinical trials containing over 11,000 patients and several on-going studies, including the EXAMINE trial which is assessing cardiovascular endpoints after treatment with alogliptin.

The EXAMINE trial is being carried out to fulfil conditions detailed in the Food and Drug Administration’s December 2008 guidance for new antidiabetics. Final results from the trial are anticipated in 2015.

Last month, the US regulators issued a second complete response letter (CRL) for the drug and the fixed-dose combination of alogliptin plus Takeda’s Actos (pioglitazone).  The FDA requested further data which the Takeda believes it can supply from post marketing data from outside the USA, as well as data from its on-going clinical programme.

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

Type 2 diabetes is the most common form of diabetes and has reached epidemic size worldwide. Roughly 366 million adults are living with type 2 diabetes globally, and the number carries on growing.  By 2030, it is predicted that one in nine adults will have the disease.  The international healthcare costs to treat diabetes and avert its complications were projected at $376 billion in 2010. By 2030, this amount is expected to surpass $490 billion.

Alogliptin was authorised in April 2010 by the Japanese Ministry of Health, Labour and Welfare, and is currently sold under the brand name Nesina.  The fixed-dose combination got the approval in Japan in July last year and is obtainable as Liovel.

The verdict also resulted in a $10 million milestone payment to the USA’s Furiex Pharmaceuticals.  Furiex Pharmaceuticals receives royalties from Nesina and Liovel and is entitled to receive royalties from sales across Europe, if the treatment is approved.


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