Winlevi filed with FDA for acne

Cassiopea has submitted a New Drug Application (NDA) to the FDA seeking marketing approval for Winlevi (clascoterone cream 1%) for the treatment of acne. Clascoterone cream 1% is under investigation as a first-in-class topical androgen receptor inhibitor for the treatment of acne. Clascoterone is a topically delivered small molecule that penetrates the skin to reach the androgen receptors of the sebaceous gland. It aims to be the first effective and safe topical androgen inhibitor therapy that does not have systemic side effects.

In 2018 Cassiopea announced topline results from two pivotal phase III clinical trials for clascoterone cream 1% demonstrating highly statistically significant improvements for all primary clinical endpoints. No treatment-related serious adverse events among patients have been recorded during the trials; local skin reactions, if present, were similar to vehicle and predominantly classified as mild. Safety results, announced earlier this year, were confirmed in an open-label safety study for a treatment period of up to one year, with an expanded drug application surface area that included both the face and trunk. The extended duration and coverage of the topically applied drug did not increase the incidence of significant side effects.

Comment: Clascoterone cream 1% targets androgen receptors at the site of application, inhibiting the local (skin) effects of dihydrotestosterone (DHT) a key driver of acne lesion development. Laboratory studies show that clascoterone inhibits lipid production from oil producing cells (sebocytes) and reduces proinflammatory cytokines, mediators influenced by androgens. Thus, pathways that foster acne lesion development are disrupted by clascoterone. Unlike oral hormonal therapies for acne, it may be used in both male and female patients.