The Committee for Medicinal Products for Human Use, a division of the European Medicines Agency, issued the positive opinion, which is likely to be acted upon by the European Commission to make Exubera available for type 1 and 2 diabetes sufferers. The move follows similar recommendations made in the US.
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.
Pending approval, 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. Due to the revolutionary nature of Exubera; it may potentially overcome the need for repeated insulin injections; analysts have estimated worldwide sales of could reach as much as $2 billion a year.
In Europe, approximately 22.5 million people suffer from diabetes. Type 2 diabetes accounts for 85 to 95% of all diagnosed cases.