Exubera Inhaled Insulin Receives Positive Opinion from European Advisory Board f

Exubera Inhaled Insulin Receives Positive Opinion from European Advisory Board for Treatment of Type 1 and Type 2 Diabetes

The U.S. FDA advisory board and now the European advisory board are recommending the approval of inhaled insulin, it’s only a matter of time before the FDA gives it’s final approval. Pfizer Inc. announced last week that the Committee for Medicinal Products for Human Use of the European Medicines Agency issued a positive opinion recommending approval of Exubera® (insulin human), an inhalable form of insulin, for the treatment of type 1 and type 2 diabetes.

The proposed therapeutic indication for Exubera® is for the treatment of adult patients with type 2 diabetes mellitus not adequately controlled with oral antidiabetic agents and requiring insulin therapy; and for the treatment of 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, the product of a joint-development program between Sanofi-Aventis and Pfizer, is an inhaled rapid-acting insulin preparation that is inhaled into the lungs prior to each meal, using a proprietary inhalation device and powdered insulin formulation developed by Nektar Therapeutics. Exubera closely mimics the normal physiological insulin response to meals by quickly being absorbed into the bloodstream to reduce meal-related spikes in glucose levels in people with diabetes.

In Europe, approximately 22.5 million people suffer from diabetes. Type 2 diabetes accounts for 85% to 95% of all diagnosed cases. Although insulin is a very important treatment for diabetes, healthcare providers and patients are often reluctant to initiate or intensify insulin treatment. The reasons for this include concerns about lifestyle changes, compliance, disease progression and injection-related factors.

Pending approval of the European Commission, Exubera would represent a major advance in insulin delivery and would be the first non-injectable insulin available in Europe since the discovery of insulin in the 1920s.

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