Magazin
2010-10-20
London and Osaka, Japan (ots/PRNewswire) - TakedaPharmaceutical Company Limited (Takeda) today announced that TakedaGlobal Research & Development Centre (Europe), Ltd. submitted aMarketing Authorisation Application (MAA) for azilsartan medoxomil(development code: TAK-491), an angiotensin II receptor blocker(ARB), to the European Medicines Agency (EMA) for the treatment ofessential hypertension. The EMA has confirmed that the submission hasbeen validated for assessment.
High blood pressure, or hypertension, was responsible for 7.6million preventable deaths worldwide in 2001.(1) Almost half (44percent) of the adult population in Europe is affected byhypertension - much (approximately 60 percent) higher than in theUnited States and Canada.(2) Discovered by Takeda, azilsartanmedoxomil is a prodrug of the active moiety azilsartan, which lowersblood pressure by blocking the action of a vasopressor hormone,angiotensin II.(3) The discovery and development of azilsartanmedoxomil continues Takeda's commitment to the treatment ofhypertension, and builds upon the company's long-standing clinicalexperience with its previously discovered antihypertensive agentcandesartan.
The MAA submission for azilsartan medoxomil monotherapy wassupported by positive results from a clinical development programwhich included nine phase 3 clinical trials in which approximately7000 subjects with essential hypertension were enrolled of whom 4814unique subjects received at least 1 dose of azilsartan medoxomil.(4)The safety and efficacy of azilsartan medoxomil was studied forinitial therapy as a once-daily oral monotherapy or forco-administration with other antihypertensive medications, includingthe diuretics chlorthalidone and hydrochlorothiazide, and the calciumchannel blocker, amlodipine.(5) It was also studied in comparisonwith olmesartan medoxomil,(6) valsartan(6) and ramipril.(7)
Results from the phase 3 clinical trials showed azilsartanmedoxomil successfully met the primary endpoints: change in 24-hourmean systolic blood pressure (SBP) by ambulatory blood pressuremonitoring (ABPM) and key secondary endpoint, clinic SBP, producing astatistically significant and clinically meaningful lowering of bloodpressure in subjects with essential hypertension.(4) The mostcommonly reported treatment-related adverse reactions in phase 3monotherapy placebo-controlled clinical trials were dizziness,increased blood creatine phosphokinase, diarrhoea, fatigue andperipheral oedema.(8)
In April 2010, Takeda submitted a New Drug Application forazilsartan medoxomil to the U.S. Food and Drug Administration. Thefiling is currently under regulatory review.
"This MAA represents a significant milestone for our company andcarries positive clinical implications for both physicians andpatients for the treatment of essential hypertension," said SuhailNurbhai, M.D., vice president & head of Clinical Science, TakedaGlobal Research & Development Centre (Europe), Ltd. "Based on theencouraging results of phase 3 clinical studies demonstrating thecompound's efficacy, safety and tolerability, we believe azilsartanmedoxomil, once approved, will provide clinicians in Europe with animportant additional treatment for patients with essentialhypertension."
"Takeda is committed to developing treatments for patients withcardiovascular disease and for use by healthcare providers for theirpatients," said Steve Coles, Ph.D., managing director, Takeda GlobalResearch & Development Centre (Europe), Ltd. "We are proud tocontinue expanding our cardiovascular expertise in Europe topotentially address this serious health problem."
About Azilsartan Medoxomil
Discovered by Takeda, azilsartan medoxomil, also known asTAK-491, is a prodrug of the active moiety azilsartan, which lowersblood pressure by blocking the action of a vasopressor hormone,angiotensin II, either when used alone or when co-administered withother classes of antihypertensive agents.(4) Angiotensin II, avasopressor, is a hormone that naturally exists within the body andplays a key role in cardiovascular function.(3) The hormone inducescontraction, or tightening, of blood vessels and thus plays animportant role in mediating hypertension.(3) The most commonlyreported treatment-related adverse reactions occurring at a higherrate than placebo in phase 3 clinical trials (based on pooled data[40 and 80 mg doses] from monotherapy placebo-controlled studies)were dizziness (2.1%), increased blood creatine phosphokinase (1.1%),diarrhoea (1.0%), fatigue (0.8%) and peripheral oedema (0.6%).(8)
About Takeda Global Research & Development Centre (Europe), Ltd.
Based in London, England, Takeda Global Research & DevelopmentCentre (Europe), Ltd., (TGRD Europe), is a subsidiary of TakedaPharmaceutical Company Limited, the largest pharmaceutical company inJapan. TGRD Europe seeks to bring innovative products to patientsthrough a pipeline that includes compounds in development fordiabetes, cardiovascular disease, neurology, oncology and otherconditions.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based globalcompany with its main focus on pharmaceuticals. As the largestpharmaceutical company in Japan and one of the global leaders of the
industry, Takeda is committed to striving toward better healthfor individuals and progress in medicine. Additional informationabout Takeda is available through its corporate Web site,http://www.takeda.com.
---------------------------------
(1) Lawes, C. M.M., et. al., Global Burden ofBlood-Pressure-Related Disease, 2001. The Lancet. 2008; 371: 1513-18.
(2) Wolf-Maier, K. et al. Hypertension Prevalence and BloodPressure Levels in 6 European Countries, Canada, and the UnitedStates. Journal of the American Medical Association.2003;289(18):2363-2369
(3) Taubman, M. Angiotensin II. A Vasoactive Hormone WithEver-Increasing Biological Roles. Circulation Research. 2003;92:9.
(4) Data on file.
(5) Weber, M. Antihypertensive Efficacy of the New AngiotensinReceptor Blocker Azilsartan Medoxomil in Combination with Amlodipine.The Journal of Clinical Hypertension. April 2010, Vol. 12. Suppl. 1.A115.
(6) White, W., et. al. The New Angiotensin Azilsartan MedoxomilHas Superior 24-Hour Blood Pressure Lowering Efficacy to BothOlmesartan and Valsartan. The Journal of Clinical Hypertension.April 2010, Vol. 12. Suppl. 1. A116.
(7) Bonner, G. Comparison of Antihypertensive Efficacy of the newAngiotensin Receptor Blocker Azilsartan Medoxomil with Ramipril.Abstract. Presented at European Society of Hypertension meeting, June18-21 2010, in Oslo, Norway.
(8) Draft Azilsartan Medoxomil Summary of ProductCharacteristics. Page 4. Table 1.
Contacts: Julia Ellwanger Takeda Pharmaceuticals, Inc. +1-224-554-7681 julia.ellwanger@tpna.com Corporate Communications Dept. Takeda Pharmaceutical Company Limited +81-3-3278-2037 Helen Rae Packer Forbes +44-(0)20-7036-8550 helen@packerforbes.com Rob Gallo Takeda Pharmaceuticals Europe Ltd +44-203-116-8874 robert.gallo@tpeu.co.uk
ots Originaltext: Takeda Chemical IndustriesIm Internet recherchierbar: http://www.presseportal.de
Contact:CONTACT: Contacts: Julia Ellwanger, Takeda Pharmaceuticals, Inc.,+1-224-554-7681, julia.ellwanger@tpna.com. Corporate Communications Dept.,Takeda Pharmaceutical Company Limited, +81-3-3278-2037. Helen Rae, PackerForbes, +44-(0)20-7036-8550, helen@packerforbes.com. Rob Gallo, TakedaPharmaceuticals Europe Ltd, +44-203-116-8874, robert.gallo@tpeu.co.uk
Takeda Submits European Marketing Authorisation Application for Azilsartan Medoxomil, an Investigational Compound for the Treatment of Essential Hypertension
High blood pressure, or hypertension, was responsible for 7.6million preventable deaths worldwide in 2001.(1) Almost half (44percent) of the adult population in Europe is affected byhypertension - much (approximately 60 percent) higher than in theUnited States and Canada.(2) Discovered by Takeda, azilsartanmedoxomil is a prodrug of the active moiety azilsartan, which lowersblood pressure by blocking the action of a vasopressor hormone,angiotensin II.(3) The discovery and development of azilsartanmedoxomil continues Takeda's commitment to the treatment ofhypertension, and builds upon the company's long-standing clinicalexperience with its previously discovered antihypertensive agentcandesartan.
The MAA submission for azilsartan medoxomil monotherapy wassupported by positive results from a clinical development programwhich included nine phase 3 clinical trials in which approximately7000 subjects with essential hypertension were enrolled of whom 4814unique subjects received at least 1 dose of azilsartan medoxomil.(4)The safety and efficacy of azilsartan medoxomil was studied forinitial therapy as a once-daily oral monotherapy or forco-administration with other antihypertensive medications, includingthe diuretics chlorthalidone and hydrochlorothiazide, and the calciumchannel blocker, amlodipine.(5) It was also studied in comparisonwith olmesartan medoxomil,(6) valsartan(6) and ramipril.(7)
Results from the phase 3 clinical trials showed azilsartanmedoxomil successfully met the primary endpoints: change in 24-hourmean systolic blood pressure (SBP) by ambulatory blood pressuremonitoring (ABPM) and key secondary endpoint, clinic SBP, producing astatistically significant and clinically meaningful lowering of bloodpressure in subjects with essential hypertension.(4) The mostcommonly reported treatment-related adverse reactions in phase 3monotherapy placebo-controlled clinical trials were dizziness,increased blood creatine phosphokinase, diarrhoea, fatigue andperipheral oedema.(8)
In April 2010, Takeda submitted a New Drug Application forazilsartan medoxomil to the U.S. Food and Drug Administration. Thefiling is currently under regulatory review.
"This MAA represents a significant milestone for our company andcarries positive clinical implications for both physicians andpatients for the treatment of essential hypertension," said SuhailNurbhai, M.D., vice president & head of Clinical Science, TakedaGlobal Research & Development Centre (Europe), Ltd. "Based on theencouraging results of phase 3 clinical studies demonstrating thecompound's efficacy, safety and tolerability, we believe azilsartanmedoxomil, once approved, will provide clinicians in Europe with animportant additional treatment for patients with essentialhypertension."
"Takeda is committed to developing treatments for patients withcardiovascular disease and for use by healthcare providers for theirpatients," said Steve Coles, Ph.D., managing director, Takeda GlobalResearch & Development Centre (Europe), Ltd. "We are proud tocontinue expanding our cardiovascular expertise in Europe topotentially address this serious health problem."
About Azilsartan Medoxomil
Discovered by Takeda, azilsartan medoxomil, also known asTAK-491, is a prodrug of the active moiety azilsartan, which lowersblood pressure by blocking the action of a vasopressor hormone,angiotensin II, either when used alone or when co-administered withother classes of antihypertensive agents.(4) Angiotensin II, avasopressor, is a hormone that naturally exists within the body andplays a key role in cardiovascular function.(3) The hormone inducescontraction, or tightening, of blood vessels and thus plays animportant role in mediating hypertension.(3) The most commonlyreported treatment-related adverse reactions occurring at a higherrate than placebo in phase 3 clinical trials (based on pooled data[40 and 80 mg doses] from monotherapy placebo-controlled studies)were dizziness (2.1%), increased blood creatine phosphokinase (1.1%),diarrhoea (1.0%), fatigue (0.8%) and peripheral oedema (0.6%).(8)
About Takeda Global Research & Development Centre (Europe), Ltd.
Based in London, England, Takeda Global Research & DevelopmentCentre (Europe), Ltd., (TGRD Europe), is a subsidiary of TakedaPharmaceutical Company Limited, the largest pharmaceutical company inJapan. TGRD Europe seeks to bring innovative products to patientsthrough a pipeline that includes compounds in development fordiabetes, cardiovascular disease, neurology, oncology and otherconditions.
About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based globalcompany with its main focus on pharmaceuticals. As the largestpharmaceutical company in Japan and one of the global leaders of the
industry, Takeda is committed to striving toward better healthfor individuals and progress in medicine. Additional informationabout Takeda is available through its corporate Web site,http://www.takeda.com.
---------------------------------
(1) Lawes, C. M.M., et. al., Global Burden ofBlood-Pressure-Related Disease, 2001. The Lancet. 2008; 371: 1513-18.
(2) Wolf-Maier, K. et al. Hypertension Prevalence and BloodPressure Levels in 6 European Countries, Canada, and the UnitedStates. Journal of the American Medical Association.2003;289(18):2363-2369
(3) Taubman, M. Angiotensin II. A Vasoactive Hormone WithEver-Increasing Biological Roles. Circulation Research. 2003;92:9.
(4) Data on file.
(5) Weber, M. Antihypertensive Efficacy of the New AngiotensinReceptor Blocker Azilsartan Medoxomil in Combination with Amlodipine.The Journal of Clinical Hypertension. April 2010, Vol. 12. Suppl. 1.A115.
(6) White, W., et. al. The New Angiotensin Azilsartan MedoxomilHas Superior 24-Hour Blood Pressure Lowering Efficacy to BothOlmesartan and Valsartan. The Journal of Clinical Hypertension.April 2010, Vol. 12. Suppl. 1. A116.
(7) Bonner, G. Comparison of Antihypertensive Efficacy of the newAngiotensin Receptor Blocker Azilsartan Medoxomil with Ramipril.Abstract. Presented at European Society of Hypertension meeting, June18-21 2010, in Oslo, Norway.
(8) Draft Azilsartan Medoxomil Summary of ProductCharacteristics. Page 4. Table 1.
Contacts: Julia Ellwanger Takeda Pharmaceuticals, Inc. +1-224-554-7681 julia.ellwanger@tpna.com Corporate Communications Dept. Takeda Pharmaceutical Company Limited +81-3-3278-2037 Helen Rae Packer Forbes +44-(0)20-7036-8550 helen@packerforbes.com Rob Gallo Takeda Pharmaceuticals Europe Ltd +44-203-116-8874 robert.gallo@tpeu.co.uk
ots Originaltext: Takeda Chemical IndustriesIm Internet recherchierbar: http://www.presseportal.de
Contact:CONTACT: Contacts: Julia Ellwanger, Takeda Pharmaceuticals, Inc.,+1-224-554-7681, julia.ellwanger@tpna.com. Corporate Communications Dept.,Takeda Pharmaceutical Company Limited, +81-3-3278-2037. Helen Rae, PackerForbes, +44-(0)20-7036-8550, helen@packerforbes.com. Rob Gallo, TakedaPharmaceuticals Europe Ltd, +44-203-116-8874, robert.gallo@tpeu.co.uk
Takeda Chemical Industries
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