News - 17 Mar `22Vitiligo: FDA status update

New

The U.S. Food and Drug Administration (FDA) has extended the review period by three months for Incyte's application seeking approval of ruxolitinib cream (Opzelura) to treat vitiligo.

The FDA is now expected to make a decision by July 18, instead of April 18. The extension will allow FDA the time to review additional data submitted by Incyte in response to FDA's information request. 

It’s unknown exactly what sort of additional information the FDA has requested from Incyte, but the move doesn’t seem “indicative of a major concern given Opzelura is continuing its launch in atopic dermatitis (AD), and all  [potential] issues should have been addressed during the AD review,” SVB Leerink analysts wrote in a note to clients this Monday. The analysts figure the delay is “temporary and more procedural in nature versus substantive,” as the FDA could have handed down a complete response letter if it saw a reason to reject Opzelura’s vitiligo application. 

We are confident in the data from the TRuE-V clinical trial program which supports our sNDA submission for ruxolitinib cream in vitiligo, and we look forward to bringing this innovative topical treatment to patients with vitiligo in the United States for whom there are no approved therapies that address repigmentation,” said Steven Stein M.D., Chief Medical Officer, Incyte.

 

Suggested reading 


📌 Vitiligo Drug Pipeline Analysis and Market Insights Analysis

🎙 The Current State of Vitiligo Research: in this 30-min audio interview, Prof. John Harris offers an in-depth analysis on the most recent data surrounding vitiligo, and promising new therapies involving topical steroids, JAK inhibitors and more.

 

 



      FAQOther Questions

      • I have a new job - should I tell colleagues about my vitiligo?

        Starting a new job can be both exciting and nerve-wracking—especially if you’re concerned about stares or questions regarding your skin. Taking a proactive approach can help eas...

      • Isn't it just a cosmetic disorder?

        Contrary to popular belief, vitiligo is not merely a cosmetic issue but a complex autoimmune disorder that affects the body’s largest organ—along with other vital systems—and is...

      • What is vitiligo?

         Vitiligo (pronounced vit-ill-EYE-go) is a generally unpredictable skin disease that causes a gradual loss of skin color and overlying hair on different parts of the body. Cont...