Approvals In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Exubera is first inhaled insulin: Pfizer's inhaled insulin Exubera - the first of its kind - is not meant as a replacement for injectable insulins, even though it allows recipients to reach peak insulin concentrations more quickly, FDA Center for Drug Evaluation & Research Director Steven Galson emphasizes in announcing approval Jan. 27. Pfizer plans to launch the product by summer. Exubera, a short-acting insulin, is indicated for "the treatment of adult patients with diabetes mellitus for the control of hyperglycemia." In patients with type 1 diabetes, Exubera should be used with longer-acting insulin. In patients with type 2 diabetes, Exubera can be used as monotherapy or in combination with oral agents or longer-acting insulins, labeling states. A recommendation for patients to get lung function tests every six to 12 months will continue until the agency has more information on Exubera's effect on the lungs from post-marketing studies. Pfizer acquired Sanofi-Aventis' marketing rights to Exubera for $1.3 bil. in January, building on the firms' previous co-development alliance (1Pharmaceutical Approvals Monthly January 2006, p. 42)...