Aclaris Therapeutics, Inc. has submitted a Marketing Authorization Application (MAA) with the Medicines Product Agency (MPA) in Sweden for its product candidate A-101 40% Topical Solution for the treatment of seborrheic keratosis. The MPA will act as the reference member state in this decentralized procedure for review of the MAA for potential marketing approval throughout Europe. If approved, A-101 40% Topical Solution would be available to be commercialized in 16 countries in the European Union.
Existing treatments for seborrheic keratosis (SK) lesions are often painful and invasive, and can have undesirable outcomes such as pigmentary changes or scarring. Fewer than 10 percent of people in the US 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 MAA submission. In these trials, A-101 40% Topical Solution 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.
“This MAA submission represents a major step toward our goal of delivering a novel, topical treatment to address a significant unmet need in the dermatology market,” said Dr. Neal Walker, President and Chief Executive Officer of Aclaris. “If approved, we believe A-101 will have broad appeal across aesthetic and medical dermatology patients—both men and women.”Next Story