Today, the FDA Endocrinologic and Metabolic Drugs Advisory Committee voted to recommend approval of a drug ingested through an inhalation system to treat type 1 and type 2 diabetes.
The committee discussed the efficacy and safety of the three- and six-unit cartridges designed for oral inhalation. The drug (Afrezza, MannKind Corp.) has been proposed to improve glycemic control in adult patients with type 1 or type 2 diabetes.
The committee voted 13-1 (with one non-voting member) to recommend approval of the drug for use as a prandial medication in type 1 diabetes, and 14-0 (with one non-voting member) to recommend approval for use in type 2 diabetes.
The drug was first submitted to the FDA in March 2009, followed by “a complex regulatory history, including two previous cycles of review that resulted in issuance of Complete Response Letters on March 12, 2010 and January 18, 2011 due to multiple identified deficiencies in the application,” according to background documents provided by the FDA committee.