Incyte Announces U.S. FDA Approval of Opzelura (ruxolitinib) Cream, a Topical JAK Inhibitor, for the Treatment of Atopic Dermatitis (AD) - Seite 2

“It can be hard for people to fully appreciate how difficult AD can be and the tremendous impact it has on patients,” said Julie Block, President & CEO, National Eczema Association. “The chronic itch is difficult to cope with and related sleep issues can be exhausting. Many patients and their dermatologists are looking for additional options to meet current unmet needs in the management of AD. The approval of Opzelura is exciting news, and we welcome a new treatment option for our community.”

AD is a chronic skin disease affecting more than 21 million people aged 12 years and older in the U.S. and is characterized by inflammation and itch³. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral and fungal infections⁴.

Incyte is committed to supporting patients and removing barriers to access medicines. Eligible patients in the U.S. who are prescribed Opzelura have access to IncyteCARES (Connecting to Access, Reimbursement, Education and Support), a program offering patient support, including financial assistance and ongoing education and resources to eligible patients. For more information about IncyteCARES, please visit www.incytecares.com or call 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. ET.

Conference Call Information

Incyte will host an analyst and investor conference call and webcast on September 22, 2021, at 8:00 a.m. ET. The live and archived webcast will be available via investor.incyte.com.

To access the conference call, please dial 877-407-3042 for domestic callers or [phone] for international callers (conference identification number 13723195).

If you are unable to participate, a replay will be available for 90 days. The replay dial-in number for the United States is 877-660-6853 and the dial-in number for international callers is [phone] (conference identification number 13723195).

About TRuE-AD

The TRuE-AD clinical trial program evaluating the safety and efficacy of ruxolitinib cream compared to vehicle (non-medicated cream) in patients with atopic dermatitis (AD) consists of two randomized, double-blind, vehicle-controlled Phase 3 studies: TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651). Both studies enrolled more than 600 patients (age ≥12 years) who had been previously diagnosed with AD for at least two years and who were candidates for topical therapy.