Sanofi-Aventis and Pfizer say they have filed their inhaled insulin product, Exubera, with the US Food and Drug Administration and that the latter has accepted the application.
Exubera – a dry powder form of insulin that is inhaled into the lungs prior to eating – is being developed for patients with type 1 and type 2 diabetes, and the firms say it has been studied in more than 3,500 patients, some for more than seven years. Recent data showed that the drug was effective in controlling blood glucose levels in patients with type 2 diabetes over a two-year period [[08/09/04c]]. However, the product’s journey thus far has not been without its pitfalls. Its route to approval was delayed after some clinical trial patients experienced a small decline in lung function [[03/05/02b]]. The drug has since been filed with the European regulators [[04/03/04a]], although questions arose after rumours over a possible regulatory rejection surfaced [[09/08/04d]].
The companies estimate that almost 180 million people around the world suffer from diabetes – a figure that could rise to 300 million in the next 20 years. More than half of people with diabetes remain uncontrolled or poorly controlled and are at risk for common complications such as heart disease, stroke, kidney failure, nerve damage and blindness