Aclaris

FDA Approves ESKATA Topical SK Treatment

New treatment for raised seborrheic keratoses

The U.S. Food and Drug Administration (FDA) has approved Aclaris Therapeutics’ ESKATA (hydrogen peroxide) topical solution, 40% for the treatment of raised seborrheic keratoses (SKs). The proprietary, high-concentration hydrogen peroxide-based topical solution is applied directly to the raised SKs by a healthcare provider using a pen-like applicator. The approval was based on two pivotal Phase 3 trials that demonstrated the safety and efficacy of ESKATA for the treatment of raised SKs.

FDA Accepts NDA for First Noninvasive, Topical SK Treatment

Topical SK Treatment Under Review

The U.S. Food & Drug Administration has accepted Aclaris Therapeutics’ New Drug Application (NDA) for A-101 40% topical solution, a high-concentration hydrogen peroxide formulation for the treatment of seborrheic keratosis (SK).

The NDA indicates that the company’s application is sufficiently complete to permit a substantive review. The Prescription Drug User Fee Act (PDUFA) target action date for the completion of the FDA’s review of the NDA is December 24, 2017. If approved, A-101 40% would be the first FDA-approved topical medication for the treatment of SK.