MannKind’s Inhaled Diabetes Treatment Approved by FDA
The FDA approved Los Angeles-based MannKind Corp.’s rapid-acting inhaled insulin Afrezza Inhalation Powder to control blood sugar levels in adults with common type 2 diabetes during meals.
The drug must be used in combination with long-acting insulin in patients with type 1 diabetes, the FDA said, and it’s not recommended for the treatment of diabetic ketoacidosis or in patients who smoke.
The approval of Afrezza broadens the options available for delivering mealtime insulin in the overall management of diabetic patients, said Jean-Marc Guettier, director of CDER’s Division of Metabolism and Endocrinology Products.
Afrezza will become the only inhaled insulin product on the market.
Alfred Mann, chief executive officer of MannKind, said the drug’s approval validates years of clinical research. “We believe that Afrezza’s distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated,” he said.
The drug comes with a Risk Evaluation and Mitigation Strategy, which includes a warning to prescribers about serious risks of acute bronchospasm. Afrezza also contains a Boxed Warning advising that acute bronchospasm has been observed in patients with asthma and chronic obstructive pulmonary disease (COPD).
In addition, the FDA is requiring post-marketing studies for Afrezza, including clinical trials to evaluate pharmacokinetics, safety and efficacy in pediatric patients, and to evaluate the potential risk of pulmonary malignancy with Afrezza. The latter trial also will assess cardiovascular risk and the long-term effect of Afrezza on pulmonary function.
According to the FDA, an estimated 25.8 million people in the U.S. have diabetes. Analysts have projected that Afrezza could become a blockbuster drug, unlike Pfizer’s inhaled insulin product, Exubera, which the drugmaker introduced in 2006 but pulled the next year due to lackluster sales. — Jonathon Shacat
Originally appeared in Drug Industry Daily, the pharmaceutical industry’s number one source for regulatory news and information. Click here for more information.