Crisaborole ointment filed with FDA for atopic dermatitis- Anacor Pharmaceuticals

Anacor Pharmaceuticals announced that the 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. The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA's review is January 7, 2017.

In July 2015, Anacor announced the positive top-line results from its two Phase III pivotal studies of crisaborole. In each of the two Phase III 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 III pivotal studies when used intermittently for up to 12 months.

Comment: Crisaborole is a novel boron-containing small molecule and, although the specific mechanism of action is not yet completely defined, Anacor believes that crisaborole inhibits PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of atopic dermatitis.