The approval is a major boost for the company that has invested approximately $1 billion in the development of the drug. The company is presently awaiting a final decision from the FDA on whether or not to approve the drug for sale in the US, the world’s biggest market for pharmaceutical products.
Exubera is the first non-injectable, inhalable form of insulin to be approved since the discovery of insulin in the 1920s.
Healthcare providers and patients have been reluctant to initiate or intensify insulin therapy when it is required due to the need for daily injections, a problem which may be overcome by an inhaled version of insulin.
According to the World Health Organization, diabetes has reached epidemic proportions and affects approximately 48 million people in Europe alone. People with diabetes often suffer from debilitating complications due to uncontrolled blood sugar levels including heart disease, amputation, blindness and kidney failure.
“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 CEO. “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.”