Print“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, says Alfred Mann, MannKind CEO.”
The U.S. Food and Drug Administration, on Friday, gave the green light to MannKind to market Afrezza to improve glycemic control in adults with both type 1 and type 2 diabetes. Approval of the rapidly acting inhaled insulin gives the more than 26 million Americans with diabetes another option to injecting insulin as a way to manage their disease.
Over time, high blood sugar levels in diabetics can increase the risk for serious complications, including heart disease, blindness and nerve and kidney damage. Many patients need to take insulin at mealtime to control glucose levels in their blood.
“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,” says Jean-Marc Guettier, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
The FDA noted that Afrezza is not a substitute for long-acting insulin and must be used in combination with long-acting insulin by patients with type 1 diabetes. It carries a boxed warning about the possibility of bronchial spasms in patients with asthma and other lung diseases. The FDA’s approval also comes with a Risk Evaluation and Mitigation Strategy that includes post-marketing studies, including evaluating the safety of the long-term use of inhaled insulin and whether it raises the risk of lung cancer.
Afrezza’s approval caps almost ten years of effort by MannKind as it struggled to get its inhaled insulin on the market and the third time that it had applied to the FDA for marketing approval.
MannKind first announced results of a late stage trial of Afrezza in September 2006. One year later, Pfizer pulled its inhaled insulin drug Exubera from the market due to lack of sales and a few months later Eli Lilly stopped development of its inhaled insulin. It wasn’t until two and a half years later in March 2009 that MannKind submitted a New Drug Application to the FDA, which was rejected one year later. MannKind resubmitted an NDA in June 2010 that was again rejected in January 2011.
“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,” says Alfred Mann, MannKind CEO and the billionaire who has pumped more than $900 million into the company during its troubled history.
While Afrezza’s inhaler is much smaller and improved over Exubera’s inhaler, MannKind has yet to sign up a partner to help it commercialize and market the drug, which will be crucial for its ultimate success. The biotech, which had repeatedly assured investors over the years that it was negotiating with potential partners, must now finalize a deal.
June 30, 2014
http://www.burrillreport.com/article-fda_approves_afrezza_to_treat_diabetes.html
