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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
- Can a gluten-free diet help with vitiligo?
It's very unlikely. We have specifically looked into claims that gluten-free diet may ease symptoms of vitiligo, or completely reverse it, and found no firm scientific evidence ...
- What tests for vitiligo should be done?
Before starting vitiligo therapy, several tests may be recommended to ensure an accurate diagnosis and appropriate treatment plan: Physical Examination A thorough physical exa...
- Is there a traditional medicine to treat vitiligo?
Traditional remedies can play a supportive role in managing chronic, metabolic, and stress-related conditionsâparticularly early in the disease process, before significant tissu...
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.
Many people deal with vitiligo while remaining in the public eye, maintaining a positive outlook, and having a successful career.
Copyright (C) BodolĂłczki JĂșliaBy taking a little time to fill in the anonymous questionnaire, you can help researchers better understand and fight vitiligo.