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MannKind Corporation resubmitted the new drug application (NDA) of Afrezza to the U.S. Food and Drug Administration (FDA). MannKind is looking to get Afrezza approved with an indication to improve glycemic control in adult patients suffering from type I or type II diabetes.
The NDA resubmission was on the basis of positive results from the Afrezza clinical development program and also from two phase III studies, study 171 (type I diabetes) and study 175 (type II diabetes).
We note that MannKind had suffered a setback when the FDA issued a second complete response letter (CRL) for Afrezza in Jan 2012. While issuing the CRL, the FDA asked the company to conduct two phase III trials (study 171 and study 175) with the next-generation inhaler.
Results from study 171 (n= 518) revealed that non-inferior decreases in A1c levels were observed in Afrezza treated patients compared to the insulin aspart group. This was the primary objective of the study. Afrezza was found to be well tolerated during the study.
Results from the study 175 (n=353) showed that the primary objective of superior reductions in A1c levels from baseline was observed in the Afrezza group compared to the comparator oral-therapy group. Also, more patients under the Afrezza group reached specified A1c target levels compared to those in the comparator oral-therapy group. The candidate was generally well tolerated in this study as well.
The positive results from the company’s lead candidate were encouraging. We expect investor focus to remain on Afrezza going forward. However, we remain concerned about the company’s over dependence on Afrezza. Any setback related to the diabetes candidate will be catastrophic for MannKind.
MannKind presently carries a Zacks Rank #3 (Hold). Other stocks, such as Actelion Ltd. ( ALIOF - Snapshot Report) , Alexion Pharmaceuticals, Inc. ( ALXN - Analyst Report) and Isis Pharmaceuticals, Inc. , are comparatively well placed with a Zacks Rank #1 (Strong Buy).