Afrezza, fast-acting, inhaled insulin, is approved
FDA has approved Afrezza, insulin delivered through a small inhaler that is believed to act more rapidly than injectable insulins such Humalog and NovoLog.
FDA has approved Afrezza, insulin delivered through a small inhaler that is believed to act more rapidly than injectable insulins such Humalog and NovoLog.
FDA said Afrezza (MannKind Corp.) offers a new treatment option for patients with diabetes.
"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," said Dr. Jean-Marc Guettier, director of the FDA's metabolic and endocrinology products division.
Afrezza will require a boxed warning of acute bronchospasm, or constriction of the airways of the lung, in patients with asthma and chronic obstructive pulmonary disease.
FDA said patients with chronic lung disease such as asthma or chronic obstructive pulmonary disease should not use Afrezza. Additionally, physicians should take a detailed medical history and conduct a physical exam to identify potential lung disease before prescribing the product. Smokers and people who recently stopped smoking should not take Afrezza, FDA said.
FDA is also requiring MannKind to conduct additional studies. Those include evaluating Afrezza's safety and efficacy in children; assessing potential increased risks for lung cancer and heart problems; and examining the way the drug works and is dosed in the body.
Afrezza is not the first inhaled, insulin product to hit the marketplace. Pfizer introduced Exubera in 2006, but withdrew it one year later because of poor sales. Novo Nordisk and Eli Lilly stopped similar development products a few years later.
MannKind’s product has been in development since 2007. It believes the initial market for Afrezza will be patients with type 2 diabetes who still have endogenous insulin production.
