MannKind resubmits NDA for diabetes drug Afrezza after positive study results
US drugmaker MannKind (Nasdaq: MNKD) has resubmitted its New Drug Application to the US Food and Drug Administration for the marketing and sale of Afrezza (insulin human [rDNA origin]) Inhalation Powder for adults with type 1 or type 2 diabetes.
In 2011, the FDA issued a complete response letter in which it raised concerns that the usage of in vitro performance data and clinical pharmacology data to bridge MannKind's next-generation inhaler to the Phase III trials conducted using its MedTone inhaler. It requested that MannKind conduct two clinical trials with the next-generation inhaler (one in patients with type 1 diabetes and one in those with type 2 disease).
Entire new data set resubmitted
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