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.
“The FDA’s acceptance of our NDA for A-101 40% is a significant achievement that brings Aclaris one step closer to providing an innovative treatment option for SK patients and the physicians who treat the condition,” said Christopher Powala, chief operating officer of Aclaris. “There is a significant need for a noninvasive, topical SK treatment as SK often appears in highly visible locations like the face and neck and can adversely affect patients’ emotional well-being.”