ACLARIS files NDA For Novel Seborrheic Keratosis Treatment

Aclaris Therapeutics, Inc. submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for A-101 40% topical solution (A-101) as a treatment for seborrheic keratosis (SK).

If approved, A-101 would be the first FDA-approved topical treatment for SK. Aclaris also plans to submit a marketing authorization application in the European Union in mid-2017.  

Existing SK treatments are often painful, invasive and can have undesirable outcomes such as pigmentary changes or scarring.  Fewer than 10% of people with SK lesions currently receive treatment.  

Positive results from two pivotal Phase 3 trials – SEBK-301 and SEBK-302 – were reported in late 2016 and provide the clinical basis for this NDA submission. In these trials, A-101 met all primary and secondary endpoints, achieving clinically and statistically significant clearance of SK lesions. The two trials, which were identical in design and together enrolled 937 patients, evaluated the safety and efficacy of A-101 compared with vehicle (placebo) in patients with four target SK lesions on the face, trunk and extremities.

Stay tuned.