Exubera(R) - (inhaled Insulin Human) - EU Marketing Authorisation For Inhaled Insulin Granted

Main Category: Diabetes
Article Date: 30 Jan 2006 - 0:00 PDT

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Exubera(R) (inhaled insulin human), the first inhaled insulin for the treatment of diabetes has been granted marketing authorisation by the European Commission.1 Granting of this authorisation within the European Union now allows manufacturing of the inhaler and the dry powder insulin formulation to commence. Exubera is not yet available on prescription in the UK or anywhere else in the world. It is anticipated that Exubera will become available in the UK in May 2006. Exubera will not be suitable for everyone with diabetes. However, for clinically appropriate adults with type 1 diabetes, or type 2 diabetes requiring insulin, Exubera will represent an important advance in the treatment options available. For those people with diabetes requiring intermediate or long-acting insulin, this treatment will still need to continue by injection.

Exubera is a fast-acting insulin, inhaled into the lungs via the mouth, shortly before meals, through a simple to use2,3, hand-held inhaler. It is the only licensed insulin delivered by inhalation rather than injection or pump.

The clinical trial programme has involved more than 3,500 adults with type 1 and type 2 diabetes.4 Exubera has been shown to be as effective as subcutaneous (injectable) insulin, including fast acting insulin, in achieving and maintaining blood sugar control in adults with either type 15,6or type 25,7diabetes.

Improved glycaemic control has been shown to result in reduced risk of microvascular complications (such as retinopathy, nephropathy and neuropathy) and associated morbidity. At present, many patients in the UK with diabetes are uncontrolled, and as many as half of type 2 patients may remain uncontrolled.8 Dissatisfaction with existing current treatment options can lead to poor blood glucose control and can be related to patient concerns. Many people with type 2 diabetes can be controlled without insulin, but initiation of insulin at the appropriate stage is likely to achieve better control. Inhaled insulin could provide a significant advantage in terms of patient acceptability and choice, helping to improve blood glucose control.

Inhaled insulin is the first non-injected option for insulin delivery since the discovery of the treatment for diabetes in the 1920s. An education and support programme for healthcare professionals on the use of inhaled insulin within the context of current management options will be launched within the next few weeks. This will ensure that, once available, healthcare professionals involved in diabetes are equipped to provide patients accurate and appropriate advice about this new insulin treatment option.

Said Dr Kate Lloyd, Medical Director, Pfizer Ltd: "Physicians face many challenges with insulin therapy, due in part to reluctance to take injections, which up until now, was the only way to deliver insulin. For successful diabetes care it is important for patients to take an active role in managing this complicated disease. Inhaled insulin is a potential option for patients where blood sugar control is difficult. The safety profile of Exubera, including the pulmonary safety profile, has been studied in adults with either type 1 or type 2 diabetes. This is reflected in the European approval of Exubera, which marks another important step forward in the treatment of diabetes, and will improve the treatment options of people with diabetes".

--- Exubera will be indicated for the treatment of:

- adult patients with type 2 diabetes mellitus not adequately controlled with oral anti-diabetic agents and requiring insulin therapy

- adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.

--- Exubera has been shown to be well-tolerated. Common side-effects observed in the clinical trials included: hypoglycaemia (comparable rates in patients treated with Exubera or subcutaneous human insulin); and cough - (predominantly mild), which tended to occur within seconds to minutes after insulin inhalation.1

--- Exubera is contra-indicated in patients with poorly controlled, unstable or severe asthma or severe Chronic Obstructive Pulmonary Disease (COPD) and smokers, or those people who have smoked within the last six months. Exubera should not be given to patients with diabetes during pregnancy.1

--- The Exubera inhaler is not breath-actuated and is different to the traditional asthma inhaler. As part of the overall training programme healthcare professionals will be advised on the appropriate use of the inhaler and how they can best teach patients to use the treatment correctly.

--- Pfizer announced on 12 January 2006 that it has reached an agreement to acquire the sanofi-aventis worldwide rights to inhaled insulin human, which will be marketed under the trade name of Exubera. The two companies were previously in a worldwide alliance to co-develop, co-promote and co-manufacture Exubera.

--- The product of a developmental collaboration between Pfizer Inc. and Nektar Therapeutics, Exubera represents a major advance in insulin delivery. Exubera is pending approval in the U.S. In September 2005, the U.S. Food and Drug Administration (FDA) Advisory Committee recommended that EXUBERA should be approved for the treatment of type 1 and type 2 diabetes in adults.

References

1- Exubera, Summary of Product Characteristics, January 2006

2- Cappelleri J, Cefalu W, Rosenstock J, Kourides I, Gerber R. Treatment satisfaction in type 2 diabetes: a comparison between an inhaled insulin regimen and a subcutaneous insulin regimen. Clinical Therapeutics 2002; 24:552-564

3- Gerber R, Cappelleri J, Kourides I, Glefand R. Treatment satisfaction with inhaled insulin in patients with type 1 diabetes. Diabetes Care 2001:24:1556-9

4- Scherbaum WA. Unlocking the opportunity of tight glycaemic control: inhaled insulin: clinical efficacy. Diabetes, Obesity and Metabolism 2005; 7 (suppl1): S9-13

5- Rosenstock J, Cappelleri J, Bolinder B, et al. Patient Satisfaction and Glycemic Control After 1 Year with Inhaled Insulin (Exubera) In Patients With Type 1 Or Type 2 Diabetes. Diabetes Care. 2004. 27: 1318-1323

6- Quattrin T, Bolanger A, Bohannon NJV, et al. Efficacy And Safety of Inhaled Insulin (Exubera) Compared with Subcutaneous Insulin Therapy In Patients With Type 1 Diabetes. Diabetes Care. 2004. 27: 2622-2627

7- Hollander PA, Blonde L, Rowe R, et al. Efficacy And Safety of Inhaled Insulin (Exubera) Compared With Subcutaneous Insulin Therapy In Patients With Type 2 Diabetes. Diabetes Care. 2004. 27: 2356-2362

8- John L, Jones K, Saleem S, Bowen-Jones D. Audit of glycaemic management in diabetics attending a DGH. Diabet Med 2005; 22 (Suppl 2): 76, Abstract P197.

About Pfizer

Pfizer, with its UK business headquarters in Surrey and global headquarters in New York, is a research-based global pharmaceutical company. Pfizer discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer treatments. Every month, over two million patients in the UK are prescribed a Pfizer medicine. It is estimated that on any given day, 40 million people around the world are treated with a Pfizer medicine.

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Registered in England
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http://www.pfizer.co.uk

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