FDA Accepts NDA for Crisaborole Topical Ointment, 2% for AD
The FDA accepted Anacor Pharmaceuticals, Inc’s New Drug Application seeking approval of crisaborole topical ointment, 2%, a novel nonsteroidal topical anti-inflammatory phosphodiesterase-4 (PDE-4) inhibitor in development for the potential treatment of mild to moderate atopic dermatitis (AD) in children and adults. The Prescription Drug User Fee Act goal date for the completion of the FDA’s review is January 7, 2017.
In July 2015, Anacor announced the positive topline results from its 2 phase 3 pivotal studies of crisaborole. In each of the 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 topline 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.
Crisaborole is a novel boron-containing small molecule. Although the specific mechanism of action is not yet completely defined, according to Anacor, crisaborole is thought to inhibit PDE-4 in target cells, which reduces the production of pro-inflammatory cytokines thought to cause the signs and symptoms of AD.