ONGLYZA™ (saxagliptin) Receives Marketing Authorisation In Europe For The Treatment Of Type 2 Diabetes

Main Category: Diabetes
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 06 Oct 2009 - 16:00 PDT

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Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE/LSE: AZN) announced that the European Commission has granted marketing authorisation for ONGLYZATM in the 27 countries of the European Union.

ONGLYZA is indicated as a once-daily 5 mg oral tablet dose in adult patients with type 2 diabetes mellitus to improve glycaemic control:

- in combination with metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control;

- in combination with a sulphonylurea, when sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate; or

- in combination with a thiazolidinedione, when the thiazolidinedione alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.

The marketing authorisation is based on data submitted from a comprehensive clinical development programme that included six core Phase III registrational trials and a Phase IIIB study comparing saxagliptin plus metformin with sitagliptin plus metformin. The registrational trials assessed the safety and efficacy of ONGLYZA and involved 4,148 patients with type 2 diabetes, including 3,021 patients treated with ONGLYZA.

ONGLYZA is the first medicine to be launched in Europe through the worldwide collaboration of Bristol-Myers Squibb and AstraZeneca to enable the companies to research, develop and commercialise select investigational medicines for the treatment of type 2 diabetes.

Béatrice Cazala, Bristol-Myers Squibb's president, Europe, and president, global commercialization, said: "The European Commission decision marks an important milestone in the alliance between Bristol-Myers Squibb and AstraZeneca. Our legacy in treating type 2 diabetes and cardiovascular disease, together with our knowledge and expertise, enables us to deliver to patients a medicine that will offer further choice for the treatment of this serious condition."

Ulf Sather, AstraZeneca's regional vice president for Europe, said: "Diabetes is a growing epidemic currently affecting some 53 million people in Europe with the number of cases expected to increase. Today's announcement is good news for those affected by type 2 diabetes and further demonstrates the commitment of AstraZeneca and Bristol-Myers Squibb to bring much needed options for the treatment of type 2 diabetes."

ONGLYZA belongs to the class of dipeptidyl peptidase-4 (DPP-4) inhibitors. These are designed to enhance the body's ability to decrease blood sugar (glucose) when it is elevated by acting on the natural hormones, incretins, thereby increasing insulin production, and by reducing the liver's production of glucose.

The launch of ONGLYZA is expected to begin in the fourth quarter of 2009.

About Type 2 Diabetes

Diabetes (diabetes mellitus) is a chronic disease in which the body does not produce or properly use insulin (a hormone that is needed for the cells of the body to properly take up glucose). This leads to elevated blood glucose levels (hyperglycemia) that are sustained over time. Sustained hyperglycemia, the hallmark of diabetes, is associated with long-term complications that can affect almost every part of the body.

The genesis of diabetes continues to be investigated, and both genetic and environmental factors such as obesity and lack of exercise appear to play a role. There are two primary underlying causes associated with type 2 diabetes: the body does not produce enough insulin (insulin deficiency), and the cells are resistant to the effect of insulin (insulin resistance).

Symptoms of type 2 diabetes develop gradually, and their onset is not as sudden as in type 1 diabetes. Symptoms may include fatigue, frequent urination, increased thirst and hunger, weight loss, blurred vision, and slow healing of wounds or sores. Some people, however, have no symptoms.

Type 2 diabetes is most often associated with older age, obesity, family history of diabetes, previous history of gestational diabetes, physical inactivity and certain ethnicities. People with type 2 diabetes often are characterised with: insulin resistance, abdominal obesity, a sedentary lifestyle, having low HDL-C ("good") cholesterol levels and high triglyceride levels and hypertension. According to the International Diabetes Federation (IDF), type 2 diabetes accounts for approximately 85 to 95 percent of all diabetes. The IDF says that across the world there are 246 million people with both types of diabetes. Taking a 90 percent figure for type 2, this equates to roughly 221 million people with type 2 diabetes globally. It is estimated there are more than 53 million people in Europe with type 2 diabetes. The International Diabetes Federation (IDF) recommends a haemoglobin A1C measurement of less than 6.5 percent for most people with type 2 diabetes.

Haemoglobin A1C is a measurement of a person's average blood glucose level over a two-to-three month period and is considered an important marker of long-term glucose control. Other important markers for type 2 diabetes include fasting plasma glucose, a measure of a person's blood glucose after at least eight hours of fasting, and postprandial glucose, a measure of a person's blood glucose after a meal.

Bristol-Myers Squibb and AstraZeneca Collaboration

Bristol-Myers Squibb and AstraZeneca entered into a collaboration in January 2007 to develop and commercialize select investigational drugs for type 2 diabetes. These therapies address two key pathways in managing type 2 diabetes and seek to expand the range of current and future therapeutic options. Our collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of patients living with type 2 diabetes.

Source
Bristol-Myers Squibb
Astrazeneca

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