There are times when you hold new technology in your hands and realize that you are looking at something special, something that will, to use an oft-cited cliché, be a “game-changer.”
A lot of times this realization happens in conjunction with consumer electronics; I remember the first time I held a compact disc and thought what a leap it represented compared to current technology; for others it might have been the first time you held an iPod or a smart phone; you just know you have something special in your hands – and it’s exciting. I am reminded of this because the FDA recently approved MannKind’s inhalable insulin product, Afrezza.
Inhalable insulin, by itself is not a new idea, or even a new product. In 2007, Pfizer stopped selling its inhaled insulin Exubera after it failed to gain ground on the market. Other companies have also tried to market inhaled insulin but have ended their development programs.
So what makes Afrezza so unique? It has to be its delivery system.
Back in 2010, MannKind won two ISPE Facility of the Year Awards (FOYA), for Equipment Innovation and Process Innovation. I recall being at INTERPHEX that year and visiting MannKind’s FOYA booth and being shown the Afrezza delivery device. It was small, it was compact, it fit in the palm of your hand, it could easily go in your pocket or purse it was, what I thought, a game-changer.
The road to get Afrezza approved has not been an easy one. The FDA had asked MannKind for numerous additional clinical trials along the way to approval, and the product as approved does carry an FDA “black box” warning – the strongest warning issued by the FDA for approved products.
But its approved and now on the market – and I predict it will be a success.