MannKind Told More Trials Needed for Afrezza Inhaler

MannKind has received a second complete response letter for its inhaled insulin Afrezza requesting two new clinical trials to make up for what one analyst calls a “regulatory shortcut.” Another analyst, however, says the FDA’s action points to a trend of “unfair” regulatory policy. The FDA raised concerns with MannKind’s use of in-vitro performance data and clinical pharmacology data to bridge the next-generation version of the Afrezza (insulin human [rDNA origin]) inhaler to the earlier model used in the company’s Phase III trials, MannKind said.
Clinical Trials Advisor