The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) has voted in favor of MannKind’s Afrezza inhaled insulin for both Type 1 and Type 2 diabetes. The vote was 13-1 in agreement that the product is safe and effective for Type 1 diabetes, with 1 abstention; 14 -0 in agreement that it is safe and effective for Type 2 diabetes.
MannKind Chairman and CEO Alfred Mann said, “”We are pleased with the Advisory Committee’s approval recommendation in support of Afrezza, and we appreciate the thoroughness of their review. We look forward to working with the FDA as they complete their evaluation of Afrezza. Diabetes is a major health problem in the United States, and we are committed to bring Afrezza to the many patients who might benefit from this novel product.”
Read the MannKind press release.
