Pfizer, Sanofi-Aventis Submit NDA for Diabetes Drug Exubera

Pfizer and sanofi-aventis have initiated the application process for its highly anticipated diabetes drug Exubera.

The companies recently filed a new drug application (NDA) for Exubera (inhaled human insulin powder), and announced that the filing has been formally accepted by the FDA. The drugmakers are seeking approval to market Exubera to adult patients with Type 1 and Type 2 diabetes. The drug is currently also under review by the European Medicines Agency.

Exubera has a distinct advantage over other insulin products because as an inhalant it is easier to administer than injected insulin.

Ratings agency Standard & Poor's recently named Exubera one of its top 10 products to watch in 2005, noting that the drug will be particularly important to Pfizer, which is facing increasing competition to cholesterol-lowering drug Lipitor (atorvastin calcium) and safety questions about its Cox-2 drugs Celebrex (celecoxib) and Bextra (valdecoxib).