Aventis and Pfizer Inc announced that the European Medicines Evaluation Agency (EMEA) has accepted the filing of a marketing authorization application for Exubera (human insulin powder). The companies seek approval to market Exubera for adult patients with Type 1 and Type 2 diabetes. Pfizer and Aventis have been working with the US Food and Drug and Administration to determine the appropriate timing for submission of the Exubera new drug application in the US.

Exubera is a dry powder form of insulin that is inhaled into the lungs prior to eating. Inhaled insulin closely mimics the normal physiological insulin response to meals, by quickly being absorbed into the bloodstream to reduce meal-related spikes in glucose levels.

It is estimated that nearly 150 million people worldwide suffer from diabetes, and the number is expected to rise to 300 million people in the next 20 years. Complications commonly associated with uncontrolled or poorly controlled diabetes include heart disease, stroke, kidney failure and blindness. Currently, diabetes and its complications account for more than $100 billion in healthcare costs annually in the United States.

Exubera is being developed for patients with Type 1 and Type 2 diabetes through a collaboration between Pfizer Inc and Aventis. The two companies have entered into a global agreement to co-develop, co-promote (where permitted by local law) and co-manufacture inhaled insulin. Pfizer is also in collaboration with Nektar Therapeutics, developers of the inhalation device and formulation.