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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.
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FAQOther Questions
- What causes vitiligo?
Surprisingly, the causes of vitiligo are yet to be precisely established. Researchers know the cause is pre-wired in your genes, just waiting for a bad luck moment. In about hal...
- Shall I take vitamin D for my vitiligo?
Vitamin D plays a central role in the prevention of different inflammatory and chronic diseases. Consuming 1,000–4,000 IU (25–100 mcg) of vitamin D3 daily should be ideal for mo...
- Is vitiligo contagious?
Vitiligo is not contagious. This means it cannot be spread from person to person through physical contact, sharing personal items, or any other means of transmission. Vitiligo ...
Though it is not always easy to treat vitiligo, there is much to be gained by clearly understanding the diagnosis, the future implications, treatment options and their outcomes.
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Copyright (C) Bodolóczki JúliaBy taking a little time to fill in the anonymous questionnaire, you can help researchers better understand and fight vitiligo.