OSAKA, Japan I July 26, 2013 I Takeda Pharmaceutical Company Limited (Takeda) today announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a positive opinion for VipidiaTM (alogliptin), a dipeptidyl peptidase IV (DPP-4) inhibitor, and for the fixed dose combination (FDC) therapies VipdometTM (alogliptin-metformin) and IncresyncTM (alogliptin-pioglitazone) for the treatment of type 2 diabetes patients who are uncontrolled on existing therapies.1,2
“The number of people at risk from complications associated with type 2 diabetes continues to rise across Europe as many still fail to reach treatment goals,” said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals. “This positive opinion 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 CHMP opinion was based on data from a robust clinical trial programme involving more than 11,000 patients treated for up to four years, and two key studies, the one year data from the ENDURE[1]trial and interim data from the cardiovascular outcomes trial EXAMINE[2].
[1]Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Subjects With Type 2 Diabetes Mellitus;
[2]EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome
The efficacy of alogliptin was studied as an adjunct to diet and exercise as an add-on therapy to several other classes of anti-diabetic medications, including metformin, pioglitazone, insulin and sulfonylureas (SUs). In these studies alogliptin 25mg tablets taken once-daily, demonstrated clinically and statistically significant reductions in HbA1c, with a good overall tolerability profile and low incidence of hypoglycemia compared with active control or placebo.2-7 It has also been shown to be weight neutral and will be available in a range of doses suitable to treat patients with all stages of renal impairment, including end stage renal disease (ESRD).2
Study results indicated that alogliptin co-administered with either metformin or pioglitazone produced significant improvements in glycemic control compared with the respective monotherapies.8-10 Fixed dose combinations of alogliptin with either metformin or pioglitazone offer the additional benefit of combining two medications in one, which may help to reduce the number of pills patients must take each day.
Common adverse events reported with alogliptin include upper respiratory tract infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux (GERD), pruritus and rash.2 In patients treated with alogliptin co-administered with metformin, common adverse events include upper respiratory tract infection, nasopharyngitis, headache, abdominal pain, GERD, diarrhea, vomiting, gastritis, gastroenteritis, pruritus and rash.11 Common adverse events reported with patients treated with alogliptin co-administered with pioglitazone include upper respiratory tract infection, sinusitis, nausea, dyspepsia, abdominal pain, pruritus, peripheral edema and increased weight.12
“Type 2 diabetes is a complex disease to manage; no two patients are the same and each responds differently to medications. Therefore all patients require a treatment approach that is individualized to their needs,” commented Professor Jiten Vora, Consultant Physician and Endocrinologist, Royal Liverpool University Hospitals, Liverpool, UK. “Although there are a number of treatment options available, there is still a need to improve glycemic control in many patients, particularly those more complex patients with multiple co-morbidities who are taking many different medications. These new treatment options will further help clinicians to tailor treatment to individual patient needs and help to improve glycemic control.”
-Ends-
About Vipidia (alogliptin)
Alogliptin has been recommended by the CHMP to be indicated for the treatment of type 2 diabetes in adults aged 18 years and older to improve glycemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycemic control2
The recommended daily dose is 25mg once daily (OD), with dose flexibility for all stages of renal disease (no dose adjustment for mild renal impairment, 12.5mg OD for moderate renal impairment, 6.25mg OD for severe renal impairment or ESRD)2
DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).13 As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels13
About Vipdomet (alogliptin and metformin) fixed dose combination11
Alogliptin and metformin is a FDC therapy for the treatment of type 2 diabetes, which combines alogliptin and metformin in a single tablet. Vipdomet has been recommended by the CHMP to be indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus:
as an adjunct to diet and exercise to improve glycemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin.
in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycemic control.
About Incresync (alogliptin and pioglitazone) fixed dose combination12
Alogliptin and pioglitazone is a FDC therapy for the treatment of type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet. Incresync has been recommended by the CHMP to be indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus:
as an adjunct to diet and exercise to improve glycemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance.
in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
About type 2 diabetes
In 2012, 371 million people were living with type 2 diabetes worldwide. That number continues to grow and by 2030 it is estimated to rise to 552 million14
In 2011, the number of people with diabetes in Europe was estimated to be 52.6 million14
The number of type 2 diabetes patients is increasing in every country14
In 2011, one in 10 deaths in adults in Europe can be attributed to diabetes, representing close to 600,000 people14
Estimates indicate that more than EUR 100 billion* was spent on healthcare due to diabetes in the European region in 2011, accounting for almost one-third of global healthcare expenditures due to diabetes14
Because of the chronic nature of this disease, combination therapy is almost uniformly required to maintain diabetic control over many years of therapy15
*Based on conversion of USD 131 billion,14 where 1 EUR = 1.30911 USD as at 12 April 2013
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
References
1. European Medicines Agency. Available at: http://www.ema.europa.eu/ema/. [Link to be updated in line with CHMP opinion]
2. Data on file. Takeda Pharmaceuticals International GmBH
3. DeFronzo RA, Fleck PR, Wilson CA, et al. Efficacy and safety of dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control. Diabetes Care 2008;31(12):2315-2317.
4. Nauck MA, Ellis GC, Fleck PR, et al. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes and inadequately controlled with metformin monotherapy: a multicentre, randomised, double blind, placebo-controlled study. Int J Clin Pract 2009;63(1):46-55.
5. Pratley RE, Reusch JE-B, Fleck PR, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomised, double blind, placebo-controlled study. Curr Med Res Opin 2009;25(10):2361-2371.
6. Rosenstock J, Rendell MS, Gross JL, et al. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab 2009;11:1145-1152.
7. Pratley RE, Kipnes MS, Fleck PR, et al. Efficacy and safety of dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes, Obesity and Metabolism 2009;11:167-176.
8. Pratley RE, Wilson CA and Fleck PR. Alogliptin plus metformin combination therapy vs alogliptin or metformin monotherapy for type 2 diabetes mellitus. Presented at the 48th Annual Meeting of the European Association for the Study of Diabetes, Berlin 2012. Poster 841-P.
9. DeFronzo RA, Burant CF, Fleck PR, et al. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin treated patients with type 2 diabetes. J Clin Endocrinol Metab 2012; 97(5):1615-1622.
10. Bosi E, Ellis GC, Wilson CA, et al. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52 week, randomized, double-blind, active-controlled, parallel-group study. Diabetes, Obes and Metab 2011;13(12): 1088-1096.
11. Data on file. Takeda Pharmaceuticals International GmBH
12. Data on file. Takeda Pharmaceuticals International GmBH
13. Christopher R and Karim A. Clinical pharmacology of alogliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of type 2 diabetes. Expert Rev Clin Parmacol 2009;2(6):589-600.
14. International Diabetes Federation. IDF Diabetes Atlas, 5th edition. Brussels, Belgium. Last accessed 4 April 2013, available at:http://www.idf.org/diabetesatlas.
15. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes: a patient centred approach. Position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2012;35(6):1364-1379
SOURCE: Takeda Pharmaceutical Co
Post Views: 70
OSAKA, Japan I July 26, 2013 I Takeda Pharmaceutical Company Limited (Takeda) today announced that the Committee for Medicinal Products for Human Use (CHMP), of the European Medicines Agency (EMA), has issued a positive opinion for VipidiaTM (alogliptin), a dipeptidyl peptidase IV (DPP-4) inhibitor, and for the fixed dose combination (FDC) therapies VipdometTM (alogliptin-metformin) and IncresyncTM (alogliptin-pioglitazone) for the treatment of type 2 diabetes patients who are uncontrolled on existing therapies.1,2
“The number of people at risk from complications associated with type 2 diabetes continues to rise across Europe as many still fail to reach treatment goals,” said Trevor Smith, Head of Commercial Operations, Europe & Canada, Takeda Pharmaceuticals. “This positive opinion 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 CHMP opinion was based on data from a robust clinical trial programme involving more than 11,000 patients treated for up to four years, and two key studies, the one year data from the ENDURE[1]trial and interim data from the cardiovascular outcomes trial EXAMINE[2].
[1]Efficacy and Safety of Alogliptin Plus Metformin Compared to Glipizide Plus Metformin in Subjects With Type 2 Diabetes Mellitus;
[2]EXamination of CArdiovascular OutcoMes: AlogliptIN vs. Standard of CarE in Patients with Type 2 Diabetes Mellitus and Acute Coronary Syndrome
The efficacy of alogliptin was studied as an adjunct to diet and exercise as an add-on therapy to several other classes of anti-diabetic medications, including metformin, pioglitazone, insulin and sulfonylureas (SUs). In these studies alogliptin 25mg tablets taken once-daily, demonstrated clinically and statistically significant reductions in HbA1c, with a good overall tolerability profile and low incidence of hypoglycemia compared with active control or placebo.2-7 It has also been shown to be weight neutral and will be available in a range of doses suitable to treat patients with all stages of renal impairment, including end stage renal disease (ESRD).2
Study results indicated that alogliptin co-administered with either metformin or pioglitazone produced significant improvements in glycemic control compared with the respective monotherapies.8-10 Fixed dose combinations of alogliptin with either metformin or pioglitazone offer the additional benefit of combining two medications in one, which may help to reduce the number of pills patients must take each day.
Common adverse events reported with alogliptin include upper respiratory tract infection, nasopharyngitis, headache, abdominal pain, gastroesophageal reflux (GERD), pruritus and rash.2 In patients treated with alogliptin co-administered with metformin, common adverse events include upper respiratory tract infection, nasopharyngitis, headache, abdominal pain, GERD, diarrhea, vomiting, gastritis, gastroenteritis, pruritus and rash.11 Common adverse events reported with patients treated with alogliptin co-administered with pioglitazone include upper respiratory tract infection, sinusitis, nausea, dyspepsia, abdominal pain, pruritus, peripheral edema and increased weight.12
“Type 2 diabetes is a complex disease to manage; no two patients are the same and each responds differently to medications. Therefore all patients require a treatment approach that is individualized to their needs,” commented Professor Jiten Vora, Consultant Physician and Endocrinologist, Royal Liverpool University Hospitals, Liverpool, UK. “Although there are a number of treatment options available, there is still a need to improve glycemic control in many patients, particularly those more complex patients with multiple co-morbidities who are taking many different medications. These new treatment options will further help clinicians to tailor treatment to individual patient needs and help to improve glycemic control.”
-Ends-
About Vipidia (alogliptin)
Alogliptin has been recommended by the CHMP to be indicated for the treatment of type 2 diabetes in adults aged 18 years and older to improve glycemic control in combination with other glucose lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycemic control2
The recommended daily dose is 25mg once daily (OD), with dose flexibility for all stages of renal disease (no dose adjustment for mild renal impairment, 12.5mg OD for moderate renal impairment, 6.25mg OD for severe renal impairment or ESRD)2
DPP-4 inhibitors address insulin deficiency by slowing the inactivation of incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic peptide).13 As a result, an increased amount of active incretins enables the pancreas to secrete insulin in a glucose-dependent manner, thereby assisting in the management of blood glucose levels13
About Vipdomet (alogliptin and metformin) fixed dose combination11
Alogliptin and metformin is a FDC therapy for the treatment of type 2 diabetes, which combines alogliptin and metformin in a single tablet. Vipdomet has been recommended by the CHMP to be indicated in the treatment of adult patients aged 18 years and older with type 2 diabetes mellitus:
as an adjunct to diet and exercise to improve glycemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin.
in combination with pioglitazone (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
in combination with insulin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycemic control in patients when insulin at a stable dose and metformin alone do not provide adequate glycemic control.
About Incresync (alogliptin and pioglitazone) fixed dose combination12
Alogliptin and pioglitazone is a FDC therapy for the treatment of type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet. Incresync has been recommended by the CHMP to be indicated as a second or third line treatment in adult patients aged 18 years and older with type 2 diabetes mellitus:
as an adjunct to diet and exercise to improve glycemic control in adult patients (particularly overweight patients) inadequately controlled on pioglitazone alone, and for whom metformin is inappropriate due to contraindications or intolerance.
in combination with metformin (i.e. triple combination therapy) as an adjunct to diet and exercise to improve glycemic control in adult patients (particularly overweight patients) inadequately controlled on their maximal tolerated dose of metformin and pioglitazone.
About type 2 diabetes
In 2012, 371 million people were living with type 2 diabetes worldwide. That number continues to grow and by 2030 it is estimated to rise to 552 million14
In 2011, the number of people with diabetes in Europe was estimated to be 52.6 million14
The number of type 2 diabetes patients is increasing in every country14
In 2011, one in 10 deaths in adults in Europe can be attributed to diabetes, representing close to 600,000 people14
Estimates indicate that more than EUR 100 billion* was spent on healthcare due to diabetes in the European region in 2011, accounting for almost one-third of global healthcare expenditures due to diabetes14
Because of the chronic nature of this disease, combination therapy is almost uniformly required to maintain diabetic control over many years of therapy15
*Based on conversion of USD 131 billion,14 where 1 EUR = 1.30911 USD as at 12 April 2013
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for people worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.
References
1. European Medicines Agency. Available at: http://www.ema.europa.eu/ema/. [Link to be updated in line with CHMP opinion]
2. Data on file. Takeda Pharmaceuticals International GmBH
3. DeFronzo RA, Fleck PR, Wilson CA, et al. Efficacy and safety of dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes and inadequate glycemic control. Diabetes Care 2008;31(12):2315-2317.
4. Nauck MA, Ellis GC, Fleck PR, et al. Efficacy and safety of adding the dipeptidyl peptidase-4 inhibitor alogliptin to metformin therapy in patients with type 2 diabetes and inadequately controlled with metformin monotherapy: a multicentre, randomised, double blind, placebo-controlled study. Int J Clin Pract 2009;63(1):46-55.
5. Pratley RE, Reusch JE-B, Fleck PR, et al. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor alogliptin added to pioglitazone in patients with type 2 diabetes: a randomised, double blind, placebo-controlled study. Curr Med Res Opin 2009;25(10):2361-2371.
6. Rosenstock J, Rendell MS, Gross JL, et al. Alogliptin added to insulin therapy in patients with type 2 diabetes reduces HbA1c without causing weight gain or increased hypoglycaemia. Diabetes Obes Metab 2009;11:1145-1152.
7. Pratley RE, Kipnes MS, Fleck PR, et al. Efficacy and safety of dipeptidyl peptidase-4 inhibitor alogliptin in patients with type 2 diabetes inadequately controlled by glyburide monotherapy. Diabetes, Obesity and Metabolism 2009;11:167-176.
8. Pratley RE, Wilson CA and Fleck PR. Alogliptin plus metformin combination therapy vs alogliptin or metformin monotherapy for type 2 diabetes mellitus. Presented at the 48th Annual Meeting of the European Association for the Study of Diabetes, Berlin 2012. Poster 841-P.
9. DeFronzo RA, Burant CF, Fleck PR, et al. Efficacy and tolerability of the DPP-4 inhibitor alogliptin combined with pioglitazone, in metformin treated patients with type 2 diabetes. J Clin Endocrinol Metab 2012; 97(5):1615-1622.
10. Bosi E, Ellis GC, Wilson CA, et al. Alogliptin as a third oral antidiabetic drug in patients with type 2 diabetes and inadequate glycaemic control on metformin and pioglitazone: a 52 week, randomized, double-blind, active-controlled, parallel-group study. Diabetes, Obes and Metab 2011;13(12): 1088-1096.
11. Data on file. Takeda Pharmaceuticals International GmBH
12. Data on file. Takeda Pharmaceuticals International GmBH
13. Christopher R and Karim A. Clinical pharmacology of alogliptin, a dipeptidyl peptidase-4 inhibitor, for the treatment of type 2 diabetes. Expert Rev Clin Parmacol 2009;2(6):589-600.
14. International Diabetes Federation. IDF Diabetes Atlas, 5th edition. Brussels, Belgium. Last accessed 4 April 2013, available at:http://www.idf.org/diabetesatlas.
15. Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycaemia in type 2 diabetes: a patient centred approach. Position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2012;35(6):1364-1379
SOURCE: Takeda Pharmaceutical Co
Post Views: 70
