INCY - Incyte's Opzelura review to treat vitiligo extended by 3 months by FDA

The U.S. Food and Drug Administration extended the review period by three months for Incyte's (NASDAQ:INCY) application seeking extended 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 from ongoing phase 3 studies submitted by Incyte in response to the U.S. drug regulator's information request. The company said the submission of the additional information has been determined by the FDA to constitute a Major Amendment to the supplemental New Drug Application (sNDA), resulting in an extension of the action date. “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

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Incyte's Opzelura review to treat vitiligo extended by 3 months by FDA