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 con- sumer electronics; I remember the first time I held a compact disc and thought what a leap it represented compared to current technol-
ogy; 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 re-
cently 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
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
But its approved and now on the market – and I predict it will be a
It's All In The Delivery
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Inhalable insulin is not a new product. In
2007, Pfizer stopped selling Exubera after it
failed to gain market share. Other companies
have also tried to market inhaled insulin but
have ended their development programs.
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