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Takeda Pharmaceuticals has received European marketing authorization for 3 new type 2 diabetes therapies, the company announced today.
The European Commission approved the dipeptidyl peptidase IV (DPP-4) inhibitor alogliptin (Vipidia) for type 2 diabetes in adults uncontrolled with existing therapies, plus the fixed-dose combinations of alogliptin and metformin (Vipdomet) and alogliptin and pioglitazone (Incresync).
The approvals follow a positive opinion on the 3 products issued in July by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), asreported by Medscape Medical News .
The same 3 formulations of alogliptin were approved in January in the United States and launched there last month asNesina, Oseni, and Kazano, respectively, for use with diet and exercise to improve blood glucose control in adults with type 2 diabetes.
The European approvals come on the heels of a presentation earlier this month of final results from the cardiovascular safety outcomes trial known as EXAMINE at the European Society of Cardiology, in Amsterdam, with simultaneous publication in theNew England Journal of Medicine.
"Alogliptin is the first agent for the treatment of type 2 diabetes to be licensed with demonstrated CV [cardiovascular] safety outcomes data," Takeda said.
Alogliptin is not the first DPP-4 inhibitor approved in Europe.
At least 4 others are already available there: sitagliptin (Januvia, Merck), saxagliptin (Komboglyze,Onglyza, AstraZeneca/Bristol-Myers Squibb), linagliptin (Jentadueto, Trajenta, Boehringer Ingelheim/Lilly), and vildagliptin (Eucreas, Galvus, Icandra, Jalra, Xiliarx, Zomarist, Novartis).
Alogliptin is also available for the treatment of type 2 diabetes in Japan.
The European marketing approvals were based on a "robust clinical trial program" involving more than 11,000 patients treated with alogliptin alone or in fixed-dose combinations with metformin or pioglitazone, the company said.
"Although there are a number of treatment options already available, many patients still fail to meet glycemic targets, experience hypoglycemic episodes, are overweight and remain at risk from long-term complications, such as cardiovascular disease and renal impairment," Simon Heller, professor of clinical diabetes at the University of Sheffield, United Kingdom, and EXAMINE trial investigator, said in a statement.
"Today's announcement, along with the cardiovascular outcomes data from EXAMINE, means that physicians within the European Union will have access to a comprehensive range of new treatments to help eligible patients manage their disease. Flexible treatments that are convenient for patients and that can help to control the numerous and complex factors associated with type 2 diabetes, may be of value in helping to implement a more personalized approach to care," Prof. Heller added.
The European Commission approved the dipeptidyl peptidase IV (DPP-4) inhibitor alogliptin (Vipidia) for type 2 diabetes in adults uncontrolled with existing therapies, plus the fixed-dose combinations of alogliptin and metformin (Vipdomet) and alogliptin and pioglitazone (Incresync).
The approvals follow a positive opinion on the 3 products issued in July by the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP), asreported by Medscape Medical News .
The same 3 formulations of alogliptin were approved in January in the United States and launched there last month asNesina, Oseni, and Kazano, respectively, for use with diet and exercise to improve blood glucose control in adults with type 2 diabetes.
The European approvals come on the heels of a presentation earlier this month of final results from the cardiovascular safety outcomes trial known as EXAMINE at the European Society of Cardiology, in Amsterdam, with simultaneous publication in theNew England Journal of Medicine.
"Alogliptin is the first agent for the treatment of type 2 diabetes to be licensed with demonstrated CV [cardiovascular] safety outcomes data," Takeda said.
Alogliptin is not the first DPP-4 inhibitor approved in Europe.
At least 4 others are already available there: sitagliptin (Januvia, Merck), saxagliptin (Komboglyze,Onglyza, AstraZeneca/Bristol-Myers Squibb), linagliptin (Jentadueto, Trajenta, Boehringer Ingelheim/Lilly), and vildagliptin (Eucreas, Galvus, Icandra, Jalra, Xiliarx, Zomarist, Novartis).
Alogliptin is also available for the treatment of type 2 diabetes in Japan.
The European marketing approvals were based on a "robust clinical trial program" involving more than 11,000 patients treated with alogliptin alone or in fixed-dose combinations with metformin or pioglitazone, the company said.
"Although there are a number of treatment options already available, many patients still fail to meet glycemic targets, experience hypoglycemic episodes, are overweight and remain at risk from long-term complications, such as cardiovascular disease and renal impairment," Simon Heller, professor of clinical diabetes at the University of Sheffield, United Kingdom, and EXAMINE trial investigator, said in a statement.
"Today's announcement, along with the cardiovascular outcomes data from EXAMINE, means that physicians within the European Union will have access to a comprehensive range of new treatments to help eligible patients manage their disease. Flexible treatments that are convenient for patients and that can help to control the numerous and complex factors associated with type 2 diabetes, may be of value in helping to implement a more personalized approach to care," Prof. Heller added.