Opzelura is the first and only topical Janus kinase (JAK) inhibitor approved in the United States
- In Phase 3 studies, Opzelura significantly reduced the skin inflammation and itch associated with AD
- Investor conference call and webcast scheduled for September 22, 2021, at 8:00 a.m. ET
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opzelura™ (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable. Opzelura is the first and only topical formulation of a JAK inhibitor approved in the United States. Research shows dysregulation of the JAK-STAT pathway contributes to key features of AD such as itch, inflammation and skin barrier dysfunction1.
"Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled disease," said Jonathan Silverberg, M.D., Ph.D., M.P.H., Associate Professor of Dermatology and Director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine and Health Sciences. "As a clinician, I am excited to have a non-steroidal topical cream like Opzelura."
"The approval of Opzelura is an important advancement in the treatment of AD, and we are pleased to offer a novel topical treatment option that targets a pathway believed to be a source of inflammation," said Hervé Hoppenot, Chief Executive Officer, Incyte. "At Incyte, we are committed to transforming the treatment of immune-mediated dermatologic conditions like AD. We look forward to bringing Opzelura to the patient community and also continuing to explore its potential in other challenging skin diseases."
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 +1-201-389-0864 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 +1-201-612-7415 (conference identification number 13723195).
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.