FDA Prolongs Review of MannKind Insulin Drug

The U.S. Food & Drug Administration has delayed the review completion date for MannKind Corporation’s insulin drug AFREZZA Inhalation Powder, the Valencia-based company announced. The new drug application review was originally set to be completed on Dec. 29, but the federal agency stated that it will need about four additional weeks. The December target date was set in July after the company resubmitted its new drug application with additional information that was needed for review. The information requested by the agency included clinical data, updated pooled safety data related to the drug, and information on the comparability of MannKind’s next-generation delivery system to the device that was used in certain clinical studies. AFREZZA, which is administered through an inhaler, is a rapid-acting mealtime insulin therapy drug being developed for the treatment of adult patients with Type 1 and Type 2 diabetes for control of hyperglycemia. Jessica Vernabe