Regulatory filing of Exubera in the US
The FDA has accepted for filing a new drug application for ExuberaR (inhaled human insulin powder, from Pfizer and Sanofi-Aventis.
The FDA has accepted for filing a new drug application for ExuberaR (inhaled human insulin powder, from Pfizer and Sanofi-Aventis.
In conjunction with Nektar Therapeutics, Bespak, a leader in specialty medical devices, is developing the manufacturing process for the drug delivery device, which it will manufacture in its Milton Keynes facility. The timing of full-scale production is still uncertain and will depend in part on the timing of the approval process. Pfizer and Sanofi-Aventis are seeking approval to market Exubera for adult patients with type 1 and type 2 diabetes. Exubera is currently also under review by the European Medicines Evaluation Agency.
Exubera, a dry powder form of insulin that is inhaled into the lungs prior to eating using a specially designed inhalation device, has been studied in more than 3500 patients, some for more than seven years. It is estimated that nearly 180m people worldwide suffer from diabetes, and the number is expected to rise to 300m people in the next 20 years. Currently, diabetes and its complications account for more than $100bn in healthcare costs annually in the United States.
Mark Throdahl, Bespak's chief executive, said: 'We are delighted that both the US and European filings have been made and we look forward to participating in the commercial success of Exubera by supplying the delivery device.'