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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
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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 ...
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Localized vitiligo, where the white patches are limited to one or a few areas of the body, can be managed with a few treatment approaches. The best therapy usually depends on th...
- How to get insurance coverage for vitiligo treatments?
Getting insurance coverage for vitiligo treatments can be challenging, but there are several steps you can take to improve your chances For a more in-depth look, check out our ...
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