The European Commission has approved Pfizer's Exubera (inhaled human insulin) for the treatment of adults with type 1 and type 2 diabetes. Exubera is the first non-injectable, inhalable form of insulin to be approved since the discovery of insulin in the 1920s, and represents a major advance in diabetes treatment.
"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," said Hank McKinnell, Pfizer chairman and chief executive officer.
"The global incidence of diabetes is currently at epidemic levels. Millions of patients are not achieving or maintaining acceptable blood sugar levels, despite the availability of current therapies. Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease," added McKinell.
Exubera is a fast-acting, dry powder formulation of human insulin that is inhaled into the lungs via the mouth before meals using a simple-to-use, hand-held device that does not require batteries or electricity. The device, which weighs four ounces and is about the size of a carrying case for a pair of eye glasses, is designed to deliver an accurate and precise dose of insulin each time it is used.
Exubera is the result of one of the most rigorous and innovative diabetes development programs ever and Pfizer's investment now stands at over $1 billion. Pfizer invested in two state-of-the-art manufacturing facilities the world's largest insulin plant in Frankfurt, Germany, and a high-tech facility in Terre Haute, Indiana, US well ahead of regulatory actions, so that the product can reach patients as quickly as possible, states a Pfizer release.
The efficacy and safety profile of Exubera was studied in more than 2,500 adults with type 1 and type 2 diabetes for an average duration of 20 months. In studies in adults with type 1 or type 2 diabetes, Exubera was shown to be as effective as injectable insulin in achieving glycemic control. In adults with type 2 diabetes who are not sufficiently controlled with commonly used oral therapies, Exubera has been shown to provide greater improvements in glycemic control. In addition, patients who took Exubera reported greater overall treatment satisfaction and acceptance compared to insulin injections or oral therapies.
"This is really good news for physicians and patients. It is truly a clinical and scientific milestone being able to give insulin without needles. Physicians face many challenges with insulin therapy due to patients' reluctance to take injections, which up until now, was the only way to take insulin. With Exubera, patients now have another opportunity to take control of their blood sugar and take an active role in managing this complicated disease," said Chantal Mathieu, Professor of Endocrinology, University of Leuven, Belgium.
Exubera is a product of a collaboration between Pfizer Inc and Nektar Therapeutics. Pfizer recently reached an agreement to acquire the sanofi-aventis worldwide rights to Exubera. The two companies were previously in a worldwide alliance to co-develop, co-promote and co-manufacture Exubera.