Valencia, California- based MannKind has submitted a New Drug Application to the FDA to market AFRESA, an inhaled insulin product for the treatment of adults with diabetes mellitus.
MannKind’s actions come in the aftermath of a spectacular flame-out by Exubera, Pfizer’s inhaled insulin product that was once touted as a blockbuster but ended up being pulled from the market in 2007 after physicians rejected it as too costly and no better than injectible insulin.
“If you have low impact needles and very good regimens that work in my clinic or my hospital, why should I change what I do?” Michael Schulman, an editor with ChangeWave Research told BurrillReport at the time.
Exubera was also saddled with safety concerns. Some worried the stuff diminished lung function. Then, about a year ago Pfizer alerted physicians that 6 of 4,740 Exubera users developed lung cancer. All had been cigarette smokers, but the fat lady sang after that.
MannKind has addressed the safety concerns with data showing that AFRESA doesn’t accumulate in pulmonary tissue as did its predecessor, and that it doesn’t affect lung function.
And MannKind intends to pitch AFRESA as having physiologic effects that mimic endogenously released insulin more closely than its injectible counterparts.
AFRESA has a more rapid onset of action and is cleared more quickly than any other exogenously administered insulin.
It achieves peak effect 12-14 minutes after inhalation. If it’s taken at the right time, that pattern matches almost exactly the effects of endogenously released insulin release in response to a meal.
MannKind has begun discussions with potential distribution partners.
“There’s a lot of interest,” MannKind VP Matthew Pfeffer told Burrill. “The world changes when you have positive phase III data and you have filed an NDA.”
23.6 million people in the US and 246 million people worldwide have diabetes.