Takeda Announces Acceptance of European Medicines Agency Submissions for Two Fixed-Dose Combination Therapies, Alogliptin and Pioglitazone and Alogliptin and Metformin, for the Treatment of Type 2 Diabetes
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Takeda Announces Acceptance of European Medicines Agency Submissions for Two Fixed-Dose Combination Therapies, Alogliptin and Pioglitazone and Alogliptin and Metformin, for the Treatment of Type 2 Diabetes

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Takeda Announces Acceptance of European Medicines Agency Submissions for Two Fixed- Dose Combination Therapies, Alogliptin and Pioglitazone and Alogliptin and Metformin, for the Treatment of Type 2 Diabetes PR Newswire LONDON and OSAKA, Japan, June 19, 2012 LONDON and OSAKA, Japan, June 19, 2012 /PRNewswire/ -- Takeda Pharmaceutical Company Limited (Takeda) Ltd. today announced that Takeda Global Research & Development Centre (Europe) Ltd. ("TGRD Europe") received confirmation of the acceptance of submissions of Marketing Authorisation Applications (MAAs) from the European Medicines Agency (EMA) for alogliptin and pioglitazone, which combines alogliptin with pioglitazone in a single tablet, and alogliptin and metformin, which combines alogliptin with metformin in a single tablet. The EMA has confirmed that the submissions have been validated for assessment. "Takeda has been committed to researching and developing new therapies for the type 2 diabetes population for nearly 20 years, and we are confident that these submissions are another step towards helping patients in Europe who might benefit from the right combination of treatments," said Stuart Dollow, M.D., managing director, Takeda Global Research & Development Centre (Europe) Ltd. "If approved, these two new therapies both offer the benefit of combining two medications in one, which may reduce the number of pills patients must take each day.

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Takeda Announces Acceptance of European
Medicines Agency Submissions for Two Fixed-
Dose Combination Therapies, Alogliptin and
Pioglitazone and Alogliptin and Metformin, for
the Treatment of Type 2 Diabetes
PR Newswire
LONDON and OSAKA, Japan, June 19, 2012
LONDON
and
OSAKA, Japan
,
June 19, 2012
/PRNewswire/ --
Takeda Pharmaceutical Company Limited (Takeda) Ltd. today announced that
Takeda Global Research & Development Centre (
Europe
) Ltd. ("TGRD Europe")
received confirmation of the acceptance of submissions of Marketing
Authorisation Applications (MAAs) from the European Medicines Agency (EMA)
for alogliptin and pioglitazone, which combines alogliptin with pioglitazone in a
single tablet, and alogliptin and metformin, which combines alogliptin with
metformin in a single tablet. The EMA has confirmed that the submissions have
been validated for assessment.
"Takeda has been committed to researching and developing new therapies for
the type 2 diabetes population for nearly 20 years, and we are confident that
these submissions are another step towards helping patients in
Europe
who
might benefit from the right combination of treatments," said Stuart Dollow,
M.D., managing director, Takeda Global Research & Development Centre
(
Europe
) Ltd. "If approved, these two new therapies both offer the benefit of
combining two medications in one, which may reduce the number of pills
patients must take each day."
Alogliptin is a dipeptidyl peptidase IV inhibitor (DPP-4i) being investigated, as an
adjunct to diet and exercise, for the treatment of type 2 diabetes. 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). 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 levels. Pioglitazone is a
thiazolidinedione (TZD) that directly addresses insulin resistance, a condition in
which the body does not efficiently use the insulin it produces to control blood
glucose levels, and is approved in adults for the treatment of type 2 diabetes,
as an adjunct to diet and exercise. If approved, alogliptin and pioglitazone will
be a new type 2 diabetes treatment option that includes both a DPP-4i and a
TZD in a single tablet for patients in the EU.
The common adverse events (≥5%) reported in patients treated with alogliptin
co-administered with pioglitazone include nasopharyngitis, back pain, urinary
tract infection, and influenza.
In addition to alogliptin and pioglitazone, the EMA will also review the MAA
submission for the fixed-dose combination (FDC) therapy alogliptin and
metformin. Metformin is a widely used diabetes medication that acts primarily
by reducing the amount of glucose produced by the liver.
Common adverse events reported in ≥5 percent of patients treated with the
co-administration of alogliptin with metformin include upper respiratory tract
infection, nasopharyngitis, creatinine renal clearance decreased, diarrhea,
headache, hypertension, and urinary tract infection.
The MAA submission for alogliptin and pioglitazone was supported by phase 3
clinical trials involving more than 1,900 patients conducted at centers
worldwide for up to one year. Study results indicated that alogliptin and
pioglitazone produced significant improvements in glycemic control.
The application for alogliptin and metformin was supported by phase 3 clinical
trials involving more than 4,000 patients conducted at centers worldwide for up
to one year. Study results demonstrated that alogliptin co-administered with
metformin produced significant improvements in glycemic control.
These submissions were also supported by data from several ongoing studies,
including the EXAMINE (
EX
amination of C
A
rdiovascular Outco
M
es: Aloglipt
IN
vs. Standard of Car
E
in Patients with Type 2 Diabetes Mellitus and Acute
Coronary Syndrome) trial. Takeda is currently conducting the EXAMINE trial to
evaluate cardiovascular endpoints following treatment with alogliptin, to comply
with the U.S. Food and Drug Administration's (FDA) criteria outlined in the
December 2008
"Guidance for Industry: Diabetes Mellitus - Evaluating
Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." As
a company, Takeda believes the interim results from this trial meet the FDA's
cardiovascular safety guideline. Final study results are expected in 2015.
About Type 2 Diabetes
Type 2 diabetes is the most common form of diabetes and has reached
epidemic proportions globally. Approximately 366 million adults are currently
living with type 2 diabetes worldwide, and that number continues to grow. By
2030, it is estimated that one in nine adults, or 552 million adults, will be living
with the disease. The global health care expenditures to treat diabetes (both
type 1 and 2) and prevent its complications were estimated at
$376 billion
in
2010. By 2030, this number is projected to exceed
$490 billion
. Because of the
chronic nature of this disease, combination therapy is almost uniformly
required to maintain diabetic control over many years of therapy.
About Alogliptin, Alogliptin and Pioglitazone, and
Alogliptin and Metformin
An NDA for alogliptin was approved in
April 2010
by the Japanese Ministry of
Health, Labour and Welfare for the treatment of type 2 diabetes, and the
therapy is currently available under the brand name NESINA
®
in this market.
Alogliptin and pioglitazone is an FDC therapy in development for the treatment
of type 2 diabetes, which combines alogliptin and pioglitazone in a single tablet.
An NDA for the alogliptin and pioglitazone FDC was approved in
July 2011
by the
Japanese Ministry of Health, Labour and Welfare for the treatment of type 2
diabetes, and the therapy is currently available under the brand name LIOVEL
®
in this market.
The combination therapy alogliptin and metformin includes metformin, a widely
used diabetes medication that acts primarily by reducing the amount of glucose
produced by the liver.
About Takeda Global Research & Development Centre
(
Europe
) Ltd.
Based in
London, England
, Takeda Global Research & Development Centre
(
Europe
), Ltd., (TGRD Europe), is a subsidiary of Takeda Pharmaceutical
Company Limited, the largest pharmaceutical company in
Japan
. TGRD Europe
seeks to bring innovative products to patients through a pipeline that includes
compounds in development for diabetes, cardiovascular disease, neurology,
oncology and other conditions.
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 patients worldwide through leading innovation
in medicine. Additional information about Takeda is available through its
corporate website, http://www.takeda.com.