Exubera earns EU approval - look for U.S. approval any minute!

We saw the press release about an hour ago announcing that Exubera has won EU approval in the treatment of both type 2 and type 1 diabetes – even as we’re all waiting to hear about the FDA decision on Exubera, which we expect at any moment now. As usual, Europe has beat us to the drug approval punch, though perhaps by less time than is typical, depending on the FDA verdict. Not much information available yet; Pfizer CEO McKinnell is quoted on Exubera, saying “Exubera is a major, first-of-its-kind, medical breakthrough that marks another critical step forward in the treatment of diabetes, a disease that has taken an enormous human and economic toll worldwide.” In Europe, 48 million people are affected by diabetes, and one of Pfizer’s manufacturing facilities is located in Frankfurt, Germany, at what is “the world’s largest insulin plant.” We’ll be interested to follow European sales of inhaled, where HCPs have traditionally been quicker to initiate insulin therapy – while this may indicate a greater use of insulin, patients and providers also may be more comfortable with injectable. Stay tuned for more on the U.S. Exubera decision.