ARTICLE | Clinical News

Afrezza regulatory update

April 7, 2014 7:00 AM UTC

FDA's Endocrinologic and Metabolic Drugs Advisory Committee said MannKind showed that Afrezza is safe and effective to treat Type I and II diabetes. The panel voted 13-1, with 1 abstention, that Afrezza is safe and effective for Type I diabetes, and 14-0, with 1 abstention, for Type II diabetes. The PDUFA date for Afrezza, a dry powder formulation of insulin plus an inhaler, is April 15. Last month, 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. ...