MannKind Slips on Afrezza Approval Delay - Analyst Blog

The Prescription Drug User Fee Act (PDUFA) date for MannKind Corporation's MNKD Afrezza was pushed back by the FDA by three months to Jul 15, 2014 to review all the information submitted by the company. MannKind's shares were down more than 8% following the news.

MannKind is looking to get Afrezza approved for the improvement of glycemic control in adult patients suffering from type I or type II diabetes. Earlier in the month, MannKind's shares skyrocketed 73.9% after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted in favor of the approval of Afrezza. The panel voted 13-1 recommending the approval of Afrezza to improve glycemic control in adults with type I diabetes. The panel unanimously recommended (14-0) the approval of Afrezza in the U.S to improve glycemic control in adults with type II diabetes.

However, the FDA had stated in its briefing document prior to the panel vote that although the candidate demonstrated statistically superior HbA1c reduction compared to placebo, it failed to demonstrate a higher HbA1c reduction compared to Novo Nordisk's NVO NovoLog in type I diabetes patients. Moreover, the FDA was concerned with the observed safety findings on Afrezza including pulmonary safety, lung cancer risk and disease specific safety issues.

Although encouraged by the FDA panel's positive opinion, we are disappointed with the delay in approval of Afrezza. MannKind currently has no approved products and is totally dependent on the successful development of the candidate.

We note that Afrezza has been through a rough patch in the past. The FDA had previously issued two complete response letters for Afrezza. In October last year, the company resubmitted the New Drug Application of the candidate for the third time.

We expect investor focus to remain on the approval of Afrezza. Afrezza, once approved, will be the first ultra-rapid-acting mealtime insulin therapy available in the U.S.

MannKind, a biopharmaceutical company, presently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the same sector include Alexion Pharmaceuticals, Inc. ALXN and Alkermes ALKS. Both stocks carry a Zacks Rank #1 (Strong Buy).