EU green light for revolutionary insulin inhaler

The London-based European Medicines Evaluation Agency has backed Pfizer​ and Sanofi-Aventis's​ inhaled diabetes treatment Exubera, for the treatment of adults with type 1 and type 2 diabetes.

The European move follows a similar green light for Exubera from the US Food and Drug Administration advisory panel last month.

However, concern was expressed by the US panel about users' potential decreased lung capacity, which the manufacturing companies promised to study further.

Diabetes is fast reaching epidemic proportions. An estimated 180 million people around the world suffer from diabetes and experts believe the number could reach 300 million within 20 years, as an obesity epidemic triggers more cases of type 2, or adult-onset, diabetes.

Approximately 22.5 million people suffer from diabetes in Europe alone, with type 2 diabetes accounting for 85-95 per cent of all diagnosed cases.

Exubera represents a major advance in insulin delivery, promising to greatly enhance insulin compliance among diabetes sufferers, particularly those who currently require multiple daily insulin injections.

Exubera is a 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.

Marketing approval by the European Commission, a process expected to take up to 90 days, will open the door for the sale of Exubera in Europe.

Shares in Nektar rose 6.7 per cent to $16.00 (€13.3) on the Nasdaq following the news from the European panel on Thursday afternoon.

Worldwide annual sales of the drug are estimated to reach $2 bn (€1.7 bn).

Not all patients with diabetes who use Exubera will be able to give up injections altogether.

The proposed therapeutic indication for Exubera is for the treatment of adult patients with type 2 diabetes not adequately controlled with oral antidiabetic agents; and adult patients with type 1 diabetes, in addition to long or intermediate acting subcutaneous insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.

To date, more than 3,500 patients in clinical trials worldwide have taken Exubera, some for as long as seven years.

Results from Phase III clinical trials suggest that Exubera may be as efficacious as injected insulin and superior to oral agents in lowering blood glucose in patients with diabetes.

Exubera's path to market has been delayed for years over concerns it might hamper lung function.

However, in clinical studies, patients experienced a small decrease in lung capacity in the initial weeks of treatment but the changes did not worsen during two years of study and were reversible if Exubera was stopped.

Type 1 diabetes occurs when the body produces little or no insulin to control blood sugar while type 2 is seen when the body does not properly use insulin.

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.

Patient compliance with injected insulin is often poor, and complications commonly associated with uncontrolled or poorly controlled diabetes include cardiovascular disease, kidney failure and blindness.

A large study in eight major European countries has shown that the total direct medical costs for type 2 diabetes are estimated to be €29 bn each year, of which hospitalisations account for €15.9 bn.

Pfizer discovers, develops, manufactures and markets leading prescription medicines for humans and animals, and many of the world's best-known consumer products.

Sanofi-Aventis is the world's third largest pharmaceutical company, ranking number one in Europe.

Nektar Therapeutics specialises in advanced drug delivery technologies and has helped companies such as Pfizer, Roche, Chiron, and Amgen improve drug performance and optimize the delivery of their products either by creating new products or extending product lifecycles.