Aventis and Pfizer seek approval to market Exubera in Europe
The European Medicines Evaluation Agency (EMEA) has accepted the filing of a marketing authorisation application from Aventis and Pfizer for Exubera (human insulin powder).
The European Medicines Evaluation Agency (EMEA) has accepted the filing of a marketing authorisation application from Aventis and Pfizer for Exubera (human insulin powder).
The companies are seeking approval to market Exubera for adult patients with Type 1 and Type 2 diabetes.
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 being absorbed quickly into the bloodstream to reduce meal-related spikes in glucose levels.
Pfizer and Aventis have been working with the US FDA to determine the appropriate timing for submission of the Exubera new drug application in the US. Currently, diabetes and its complications account for more than $100bn in healthcare costs annually in the US.
Exubera is being developed through a collaboration between Pfizer Inc and Aventis. The two companies have entered into a global agreement to co-develop, co-promote and co-manufacture inhaled insulin. Pfizer is also in collaboration with Nektar Therapeutics, developer of the inhalation device and formulation.