FDA panel backs MannKind's Afrezza
FDA's Endocrinologic and Metabolic Drugs Advisory Committee said MannKind Corp. (NASDAQ:MNKD) showed that Afrezza is safe and effective to treat Type I and II diabetes. The panel voted 13-1, with one abstention, that Afrezza is safe and effective for Type I diabetes, and 14-0, with one abstention, for Type II diabetes. The PDUFA date for Afrezza, a dry powder formulation of insulin plus an inhaler, is April 15. The resubmitted NDA covers Afrezza delivered via the next-generation Dreamboat inhaler.
On Friday, FDA reviewers said Afrezza is effective for Type II diabetes but questioned the product's efficacy in Type I diabetes and raised potential safety concerns in briefing documents released ahead of the meeting (see BioCentury Extra, March 28). ...