Afrezza - FDA's top 10 Blockbuster Decisions

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Drug: Afrezza
Company: MannKind
PDUFA date: December 29
Peak sales: Difficult to project

Usually the first word you hear when you mention Afrezza is "Exubera," Pfizer's failed attempt at introducing the world to an inhaled insulin product. MannKind founder Alfred Mann has spent a good part of the last few years explaining over and over again that Afrezza's data indicate that his inhaled product is better than injected short-acting insulin-but he still faces a phalanx of market skeptics.

The main advantage of Exubera, though, wasn't that it was more efficacious, but that legions of diabetics would find an inhalable product a much more convenient therapy than something they had to inject. And Pfizer spent millions proving that its theory was wrong.

Adding to the doubt about Afrezza was Mann's insistence on setting a timetable for approval and a partnership that never stayed on track.

And when the FDA's complete response letter for the small device/therapy earlier this year asked for more feedback on clinical utility and the comparability of the treatment used in clinical trials and the one planned for commercial use, investors poured through the exit doors.

Provided MannKind can clear the last big hurdle between Afrezza and the marketplace, though, Mann will get his chance to prove once and for all whether he has a new approach that can revolutionize the way that diabetes is treated--earning blockbuster revenue for the company.

It may be a wild card, but this is one potential blockbuster worth watching.

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