Insulin is conventionally delivered into a diabetic's system through injection but people who suffer from diabetes now have a new option for insulin treatment after health regulators gave the go signal for insulin that is inhaled instead of being injected.
On Friday, June 28, the U.S. Food and Drug Administration announced that it has green-lighted MannKind Corporation's Afrezza, insulin in powder form that is delivered through an inhaler the size of a whistle. The drug, which needs to be administered before or within 20 minutes of each meal to improve the blood sugar level of adult diabetics, acts faster than conventional insulin that is administered via injection.
Jean-Marc Guettier, from the FDA Center for Drug Evaluation and Research Division of Metabolism and Endocrinology Products, said that the approval of Afrezza brings new option for diabetics who need mealtime insulin. "Today's approval broadens the options available for delivering mealtime insulin in the overall management of patients with diabetes who require it to control blood sugar levels," Guettier said.
FDA's approval is a long-awaited decision for Connecticut-based MannKind and its 88-year old chief executive Alfred Mann who spent a big part of his personal wealth to help sustain the company through the nearly eight years of seeking approval for its inhalable diabetes therapy. The company spent approximately $1.8 billion developing the drug, about $975 million of which came from Mann's own money.
"Approval of Afrezza is an important milestone for MannKind, as today's FDA action validates the years of clinical research and commitment that powered the development of this unique therapy," Mann said in a statement. "We thank the more than 6,500 adult patients and healthy volunteers who participated in the Afrezza clinical program."
FDA cleared Afrezza for use by individuals with Type 1 and Type 2 diabetes but prior to prescribing it, physicians need to conduct physical examinations and verify if the patient has a medical history of lung disease. The drug is not advised for use by individuals with lung problem and will, in fact, come with a warning that highlights the risks for acute bronchospasm, which is marked by the inflammation of the airways of the lungs, in patients with chronic obstructive pulmonary disease and asthma.
The drug is not also recommended for use by diabetics who smoke or have just stopped smoking. Adverse effects that were associated with use of Afrezza in clinical trials include cough, hypoglycemia irritation or pain in the throat.
