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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• Publié par: takeda-pharmaceutical-company-limited
• Nombre de lectures: 17
• Langue: English

Extrait

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.