Yesterday, MannKind Corporation annouced that the FDA voted 13-1 in favor of an approval for Afrezza. You can find the press release here.
We’ve Seen This Movie Before
For nearly a year, an inhaled insulin product (Exubera, Pfizer) was on the market. While Exubera was as effective as short-acting insulin, the high cost of the system relative to injectable insulin made it a commercial failure in the US. In fact, it was never approved in the UK due to cost concerns.
Now to be fair to MannKind, Exubera had a range of issues:
According to Nektar, the company who originally developed Exubera:
“The fact is that it hasn’t done well, and we know it has done miserable. It’s one of the worst performing products for new launch that I could ever recall. That doesn’t mean the product is flawed. The product is excellent. The launch has been flawed and Pfizer has been very open about admitting that they have really done a very poor job of launching this drug.”
Now Afrezza appears to be a much smaller, simpler device judging by the pictures.
From scanning various articles, lung function is not an issue with Afrezza…another point for MannKind.
So how will Afrezza perform commercially? That’s obviously an open question.
Assuming there is a need for physician and patient education, it’s going to take some deep pockets. And it will likely depend on what the final label actually says in order to finalize the projections and deal valuation.