News - 29 Dec `21Opzelura for vitiligo treatment is on FDA's fast track


The U.S. FDA has granted Priority Review status to Incyte's sNDA for ruxolitinib 1,5% cream to treat vitiligo.

Ruxolitinib cream is currently marketed under the brand name Opzelura for the short-term treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older. In the clinical trials it also demonstrated a ≥ 75% improvent in 30% patients' facial vitiligo after 24 weeks of treatment. A significantly greater proportion of patients achieved at least 50% improvement in total body Vitiligo Area Scoring Index and a Vitiligo Noticeability Scale response.

One financial analyst noted issues with the gritty texture of the cream that is not fully absorbed by the skin but Incyte says this issue does not affect the effectiveness and safety of the drug. Following the Opzulera news and better-than-expected financial results of the current year, the Wall Street went bullish on Incyte's stock price, with a chance of a company takeover by a larger biotech player. After all, it's the only drug candidate — and hope — for 1.5 million people living with vitiligo in the U.S. alone, of which up to 200 thousand can be treated with the company's drug once it is approved by the FDA in early 2022.

A Prescription Drug User Fee Act (Wiki) is set date on April 18, 2022.


More on the subject: 

📌 Check Vitiligo Drug Pipeline Analysis and Market Insights for other news on vitiligo drug development. There is a lot on our radar for vitiligo: studies on therapies that would block IL-15 and research on CXCL10 signaling.  

🎙 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.


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