Vindication for MannKind With FDA Panel Backing

Source: Thinkstock MannKind Corp. (NASDAQ: MNKD)had been trading as though the stock was bracing for an U.S. Food and Drug Administration (FDA) panel decision recommending against the approval of its inhalable insulin called Afrezza. On Tuesday evening, MannKind announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA voted 13 to 1 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with type 1 diabetes.

MannKind further went on to say that the FDA panel voted 14 to 0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with type 2 diabetes.

Afrezza will be the first ultra rapid-acting mealtime insulin therapy available in the United States, if it is approved. We would make the reminder here that many such approvals have failed to come even after panel recommendation. Another issue to remember is that the FDA has a history of surprise rulings, and the FDA has not exactly been considered a MannKind friend in recent market history.

The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its approval review of Afrezza is April 15, 2014.

Afrezza is an inhaled powder administered at the start of a meal, which aims to improve glycemic control in adult patients with type 1 or type 2 diabetes. This powder is delivered by an inhaler and dissolves immediately upon inhalation to the deep lung and delivers insulin quickly to the bloodstream. The company shows that peak insulin levels are achieved within 12 to 15 minutes versus 45 to 90 minutes for injected rapid acting insulin analogs and versus 90 to 150 minutes for injected regular human insulin.

Alfred Mann, Chairman and Chief Executive Officer of MannKind, 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 Afrezzato the many patients who might benefit from this novel product.”

MannKind shares were halted ahead of the news, but the drops here had been awful. The last trade on Monday was at $4.02 after closing at $4.93 on Friday and $5.20 on Thursday. Just a week earlier, MannKind shares were briefly above $6 – so it lost one-third of its value in less than two weeks. MannKind’s market cap was $1.45 billion even after the drop, and its shares have been all over the place since before the recession.