Anacor Pharma announces FDA acceptance of NDA for Crisaborole Topical Ointment, 2%
Anacor Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for review Anacor's New Drug Application (NDA) seeking approval of crisaborole topical ointment, 2%, a novel non-steroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.
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The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA's review is January 7, 2017.
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In July 2015, Anacor announced the positive top-line results from its two Phase 3 pivotal studies of crisaborole. In each of the two Phase 3 pivotal studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and demonstrated a safety profile consistent with previous studies. In October 2015, Anacor announced the top-line results from its long-term safety study, in which crisaborole was found to be well-tolerated and demonstrated a safety profile consistent with that seen in the Phase 3 pivotal studies when used intermittently for up to 12 months.