Good news flowed in at MannKind Corporation (MNKD) when the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) voted in favor of the approval of the company’s diabetes candidate, Afrezza. We expect MannKind’s share price to appreciate significantly on 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.
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.
The news comes as a relief for MannKind as the FDA had previously issued two complete response letters (CRL) for Afrezza. While issuing the last CRL in Jan 2011, the FDA asked the company to conduct two phase III trials with the next-generation inhaler. In Aug 2013, MannKind provided results from the two phase III studies (study 171 and study 175). Both studies met the primary endpoints and safety objectives.
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.
We expect investor focus to remain on the approval of Afrezza. A final decision from the U.S. regulatory body on the approval of the drug is expected by Apr 15, 2014. 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).
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