The US FDA has announced the approval of MannKind Corporation’s Afrezza inhaled insulin for the treatment of diabetes. The PDUFA date for Afrezza had been set for July 15, 2014 after the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) recommended approval of the product on April 2, 2014.
The product will have a boxed warning about bronchospasm in asthma and COPD patients, and the agency advises against use of the product by those patients or by smokers. The FDA will also require post-marketing studies, including:
- a pediatric PK, safety and efficacy trial
- a study of the risks of lung cancer, respiratory problems and cardiovascular issues
- a PK/PD euglycemic glucose-clamp clinical trial to characterize dose-response
- a PK/PD euglycemic glucose-clamp clinical trial to characterize within-subject variability
FDA Director of the Division of Metabolism and Endocrinology Products in the Center for Drug Evaluation and Research CDER) Jean-Marc Guettier commented, “Afrezza is a new treatment option for patients with diabetes requiring 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.”
MannKind CEO Alfred Mann said, “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. We are excited for patients, as 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. We thank the more than 6,500 adult patients and healthy volunteers who participated in the Afrezza clinical program.”
Read the FDA press release.
Read the MannKind press release.
