Anacor Pharma Gets FDA Acceptance of NDA

Anacor Pharmaceuticals said that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) seeking approval of crisaborole topical ointment, 2%, a 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.

“We believe there is a significant unmet medical need for a novel non-steroidal topical anti-inflammatory treatment option for the patients who are suffering with mild-to-moderate atopic dermatitis,” said Paul Berns, chairman and chief executive officer, Anacor.

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.