The first inhaled insulin has been approved by the US Food and Drug Administration (USFDA) and the European Commission, but is likely to be launched in the UK first. It 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. According to the World Health Organization (WHO), diabetes has reached epidemic proportions worldwide. People with diabetes often suffer from debilitating complications due to uncontrolled blood sugar levels including heart disease, amputation, blindness and kidney failure. The direct healthcare costs associated with diabetes are estimated to be around $286 billion worldwide, with the majority of these costs linked to treating diabetes-related complications. Since its discovery more than 80 years ago, insulin has been the gold standard treatment for diabetes. In order to achieve tight blood sugar control, insulin is often administered before meals to mimic the body's natural insulin response to food. Healthcare providers and patients have been reluctant to initiate or intensify insulin therapy when it is required due to the need for daily injections. Exubera (Pfizer) 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. Specialty UK device maker Bespak, which is gearing up to make the delivery device at its plant said the time gap before launch would allow Pfizer to train clinicians and agree upon the product labelling. According to a Pfizer spokesperson, it shall be launched in the UK in May. However, the US would not be far behind because the FDA approval had come earlier than expected. The US launch was originally anticipated to be June or July. Britain and the United States allow new products to be launched without pricing negotiations. Germany also offers companies the same advantage, so a speedy German launch is also likely.
Reuters Health,
January 2006