FDA to Review Novel Topical Treatment for Atopic Dermatitis
Anacor announced that it has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for crisaborole 2% topical ointment for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.
The NDA submission is based on positive results from two Phase 3 pivotal studies of crisaborole, both demonstrating statistical significance on all primary and secondary endpoints and consistent safety profile with previous studies. In addition, a long-term safety study for crisaborole also showed a tolerable safety profile consistent with that seen in the Phase 3 trials when used intermittently for up to 12 months.
Crisaborole 2% topical ointment is an investigational, non-steroidal, topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor.
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