Japan-based Takeda Pharmaceutical Company has received marketing authorisation (MA) from the European Commission (EC) for its three new type 2 diabetes therapies Vipidia (alogliptin), Vipdomet (alogliptin with metformin) and Incresync (alogliptin with pioglitazone).
Vipidia has been designed to treat type 2 diabetes in adults aged 18 years and older to improve glycaemic control in combination with other glucose lowering medicinal products including insulin.
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Vipdomet and Incresync will be used for the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus.
Vipdomet, a FDC therapy for the treatment of type 2 diabetes, combines 12.5mg alogliptin and 1,000mg metformin in a single tablet, taken twice daily.
Currently, the alogliptin and metformin fixed-dose combination is available in the US under the brand name Kazano.
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Incresync, indicated as a second or third line treatment for type 2 diabetes mellitus, combines 25mg alogliptin and 45mg pioglitazone in a single tablet, taken once daily.
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By GlobalDataCurrently the alogliptin and pioglitazone fixed-dose combination is available in Japan under the brand name Liovel and in the US as Oseni.
Takeda Pharmaceutical head of commercial operations for Europe and Canada Trevor Smith said the incidence of type 2 diabetes in Europe is on the rise with an estimated 55 million cases in 2011 predicted to increase to an estimated 64.2 million in 2030.
"We know that many people living with type 2 diabetes struggle to manage their disease so there is a need for new therapies to assist them in doing so," Smith said.
"This marketing authorisation marks an important milestone in Takeda’s ongoing commitment in working to advance patient care and helping to meet the individual needs of this growing patient population."
The MA was granted based on data from a clinical trial programme involving treatment of over 11,000 patients for about four years and two trials, the ENDURE trial and interim data from the cardiovascular safety outcomes trial EXAMINE.
Results from the ENDURE trial indicated that alogliptin 25mg with metformin provided better durability of glycaemic control at two years with fewer hypoglycemic episodes and no negative impact on weight compared to a sulphonylurea (SU), (glipizide).
When alogliptin was given in combination with metformin, more patients achieved target HbA1c of = 7% compared with an SU in combination with metformin.
Alogliptin also demonstrated its efficacy as an add-on therapy to several other classes of anti-diabetic medications, including metformin, thiazolidinediones, insulin and SUs.
Previously conducted clinical studies with alogliptin 25mg tablets taken once daily demonstrated clinically and statistically significant reductions in HbA1c, with a good overall tolerability profile and low incidence of hypoglycaemia compared with active control or placebo.
Takeda received Japanese approval for Alogliptin (Nesina) in 2010, while the US and Chinese approvals were granted in 2013.
Image: Takeda Midosuji Building, headquarters of Takeda Pharmaceutical Company, in Chuo-ku, Osaka, Japan. Photo: courtesy of J o.
