Afrezza approval: one small step away for MannKind?

Related tags Food and drug administration

The US FDA is set to make a final approval decision on the one remaining inhalable delivery insulin product, MannKind’s Afrezza, by December 29.

MannKind has sought approval for its product for the past few years, having encountered a number of Food and Drug Administration (FDA) requests for more information and proof of clinical utility, the most recent of which was in March​.

Commenting on the latest development, CEO Alfred Mann said: “We have worked diligently since March to prepare our resubmission and we are confident that we have addressed the requests that were outlined by the FDA​.”

He added that “We will continue to work closely with the FDA during this final stage of the review process.”

So, while it is too early to say what the FDA’s decision will be, or even if it will meet the action deadline this time around​, MannKind may be getting closer to being the only drugmaker to have an inhalable insulin on the market.

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