The Food and Drug Administration (FDA) has delayed its decision about whether to approve Mannkind Corp.’s Afrezza, an inhaled insulin treatment for diabetes, due to concerns about an increased risk of lung cancer.
The delay comes just one week after an advisory panel recommended the approval of the therapy for both type 1 and type 2 diabetes under the condition that the drug company collect long-term data on cancer risks and other potential side effects.
Afrezza is a whistle-sized device designed to deliver a fast-acting dose of insulin. It offers a convenient alternative for many diabetic patients who currently have to undergo regular injections, which can be both cumbersome and painful.
There are currently no inhaled insulin products on the market since Pfizer pulled Exubera from the market in 2006 due to poor sales. Post-market studies on Exubera showed a potential link between the inhaler and lung cancer.
Four patients who were treated with Afrezza during clinical trails developed lung cancer, however panelists felt there was too little evidence to confirm a cancer risk. However, they expressed enough concern to recommend approval of the inhaled insulin provided the drug company collect post-market data on side effects.
A new date of July 15 was set to give the FDA time to fully review information on Afrezza.
The FDA has taken a closer look at health risks associated with diabetes treatments in recent years. In 2011, the agency warned that studies had linked Actos to bladder cancer. FDA researchers are also looking into a possible link between Byetta and Januvia and pancreatic cancer.