Winlevi® (clascoterone) – New drug approval

• On August 27, 2020, Cassiopea announced the FDA approval of Winlevi (clascoterone) for the topical treatment of vulgaris in patients 12 years of age and older.

• Clascoterone is an receptor inhibitor. The mechanism of action of Winlevi cream for the topical treatment of acne vulgaris is unknown.

• The safety and of Winlevi was evaluated in two randomized, vehicle-controlled clinical studies of 1,440 patients with facial acne. Efficacy was measured at week 12 and evaluated the reduction in inflammatory and non-inflammatory lesions.

— Patients treated with Winlevi demonstrated greater reductions in inflammatory and non- inflammatory lesions compared to patients in the vehicle group.

• Warnings and precautions of Winlevi include local reaction and hypothalamic-pituitary-adrenal axis suppression.

• The most common adverse reactions (7% - 12%) with Winlevi use were erythema/reddening, pruritus and scaling/dryness. Additionally, edema, stinging, and burning occurred in > 3% of patients and were reported in a similar percentage of patients treated with vehicle.

• The recommended dose of Winlevi is the application of a thin, uniform layer twice per day, in the morning and the evening to the affected area.

— Winlevi cream is for topical use only. Winlevi cream is not for ophthalmic, oral or vaginal use.

• Cassiopea’s launch plans for Winlevi are pending. Winlevi will be available as a 1% cream.

optumrx.com

OptumRx® specializes in the delivery, clinical management and affordability of prescription medications and consumer health products. We are an Optum® company — a leading provider of integrated health services. Learn more at optum.com. All Optum® trademarks and logos are owned by Optum, Inc. All other brand or product names are trademarks or registered marks of their respective owners. This document contains information that is considered proprietary to OptumRx and should not be reproduced without the express written consent of OptumRx. RxNews® is published by the OptumRx Clinical Services Department. ©2020 Optum, Inc. All rights reserved.