) 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
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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
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
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,
Alexion Pharmaceuticals, Inc.
Isis Pharmaceuticals, Inc.
), are comparatively well placed with a Zacks Rank #1 (Strong