FDA Accepts Aclaris Therapeutics’ NDA for Topical Treatment of Seborrheic Keratosis

Tuesday, May 09, 2017 | FDA Approval/Clearance

The FDA has accepted Aclaris Therapeutics' New Drug Application (NDA) for A-101 40% topical solution, an investigational drug for the potential treatment of seborrheic keratosis (SK). The NDA acceptance by the FDA in its 74-day letter indicates that the application is sufficiently complete to permit a substantive review. The 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 non-invasive, topical SK treatment as SK often appears in highly visible locations like the face and neck and can adversely affect patients’ emotional well-being.”

A-101 40% topical solution is a proprietary, high-concentration hydrogen peroxide formulation under investigation for the treatment of SK. It is being developed as a non-invasive, in-office treatment administered by physicians or other licensed health care professionals. In clinical trials, patients treated with A-101 40% achieved statistically and clinically significant improvement in clearing SK lesions compared to placebo and with a similar adverse event profile. A-101 40% is designed to work by penetrating into the SK lesion and causing oxidative damage, which can ultimately result in the sloughing of the SK cells. A-101 40% has been the focus of a robust clinical development program in which over 700 patients have been treated with A-101. The 45% concentration of A-101 is also in clinical development for the treatment of common warts.


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