Anacor Pharmaceuticals announced that the Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) of crisaborole 2% topical ointment for the potential treatment of mild-to-moderate atopic dermatitis in children and adults.
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of January 7, 2017 to complete the review of the NDA.
Anacor announced positive top-line results in July 2015 from its two Phase 3 studies evaluating crisaborole in patients with mild-to-moderate atopic dermatitis. Both studies showed that crisaborole achieved statistically significant results on all primary and secondary endpoints, as well as a tolerable safety profile consistent with previous studies. Results from the company’s long-term safety study also demonstrated consistent safety profile for crisaborole 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.
For more information visit Anacor.com.