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news.Leading pharmaceuticals firms Pfizer and the Sanofi-Aventis Group have revealed that the FDA has accepted for filing a new drug application seeking marketing approval for their inhaled insulin powder, Exubera.
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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 3,500 patients, some for over seven years.
The companies seek 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 (EMEA).
Pfizer and Sanofi-Aventis have entered into a global agreement to co-develop, co-promote and co-manufacture inhaled insulin. Pfizer is also in collaboration with Nektar Therapeutics, developers of the inhalation device and formulation.
It is estimated that the number of people suffering from diabetes worldwide will rise to 300 million people in the next 20 years and the disease and its complications currently account for more than $100 billion in annual healthcare costs in the US alone.