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MannKind Corporation’s (MNKD - Analyst Report) long wait ended on a triumphant note when the FDA finally approved Afrezza for the improvement of glycemic control in adults suffering from diabetes mellitus. Afrezza becomes the first approved product at MannKind. The news comes as a huge relief for the company as the FDA had previously issued two complete response letters for the diabetes product.

The U.S. regulatory body has approved the drug for administration in diabetes patients before each meal or within 20 minutes after its commencement. However, the FDA said that Afrezza must be used in combination with long-acting insulin for treating patients suffering from type I diabetes.

Moreover, the drug was not recommended for the treatment of diabetic ketoacidosis and for patients who smoke. Afrezza also carries a boxed warning stating that there is a risk of acute bronchospasm in patients suffering from chronic lung disease.

Afrezza’s approval also comes with a Risk Evaluation and Mitigation Strategy to confirm that the benefits of Afrezza overshadow the risks of acute bronchospasm in patients suffering from chronic lung disease. Moreover, the FDA has asked for several post-marketing studies for the drug.

As per the Centers for Disease Control and Prevention there are around 29.1 million people in the U.S. affected by diabetes mellitus.

MannKind has been flying high after it received a positive opinion from the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee on Apr 1 regarding the approval of Afrezza to improve glycemic control in adults with type I and type II diabetes. Shares have soared almost 149% since then. MannKind also touched a 52-week high of $11.11 on Jun 27.

Our Take

This is a milestone event for MannKind. Though delayed, but a much needed approval comes MannKind’s way. The company will be receiving product revenues for the first time in the near future with the launch of Afrezza. Needless to say MannKind badly needed a regular source of revenues.

However, we remain concerned about the sales potential of the drug given so many limitations. In spite of the limitations, we still expect shares to rise on MannKind’s first product approval.

MannKind, a biopharmaceutical company, presently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Actelion Ltd. (ALIOF), The Medicines Co. (MDCO - Analyst Report) and Regeneron Pharmaceuticals, Inc. (REGN - Analyst Report). All stocks hold a Zacks Rank #1 (Strong Buy).

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