FDA has accepts new drug application for Exubera (inhaled human insulin powder)

Dr. John Patton, co-founder and chief scientific officer for Nektar reported that Pfizer and The Sanofi-Aventis Group have announced that the FDA has accepted for filing a new drug application for Exubera (inhaled human insulin powder).

Nektar develops and provides the inhalers and the powdered insulin for the Exubera product which is a step closer to offering a breakthrough for treating patients with diabetes, an important milestone for Exubera and for Nektar. Exubera, a dry powder form of insulin is inhaled into the lungs prior to eating using a specially designed inhalation device, has been trialed in more than 3,500 patients for more than seven years.

Pfizer and Sanofi-Aventis want 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.The two companies have entered into a global agreement to co-develop, co-promote (where permitted by local law) and co-manufacture inhaled insulin. Nektar is in collaboration with Pfizer as the developer of the inhalation device and formulation.

Nearly 180 million people worldwide suffer from diabetes, and the number is expected to rise to 300 million people 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.Diabetes and its complications account for more than $100 billion in healthcare costs annually in the United States.