It will be a tense time for Pfizer and partner Sanofi-Aventis early September as its inhaled insulin product, Exubera, comes before a US Food and Drug Administration panel as a potentially revolutionary new treatment for diabetes.
Exubera is being developed for both type 1 and type 2 diabetes and, if approved, would become the world’s first-ever inhaled insulin product – potentially capturing a large slice of the multi-billion dollar market as patients seek an alternative to daily injections.
Pfizer and Sanofi-Aventis filed for approval of Exubera back in March after an almost three-year delay caused by concerns the product may have an adverse effect on lung function [[03/03/05c]], [[03/05/02b]].
But the firms were bolstered earlier this year after three two-year studies presented at the American Diabetes Association meeting showed Exubera to provide effective, sustained glycaemic control and be well tolerated in adults with type 2 diabetes. The most common side effects reported in the trials were hypoglycaemia and cough, “with no clinically important effects on pulmonary function compared to patients treated with oral agents alone [[15/06/05d]].