INCY - Incyte wins EU nod for vitiligo cream Opzelura

Incyte ( NASDAQ: INCY ) announced Friday that a group of medical experts in the EU recommended the marketing authorization of ruxolitinib cream for non-segmental vitiligo with facial involvement in those aged 12 years and above.

The decision of the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) brings Incyte ( INCY ) one step closer to launching the JAK inhibitor, also known as Opzelura, in Europe.

Data from two pivotal Phase 3 clinical trials, which involved more than 600 people with non-segmental vitiligo aged 12 years and older, supported their decision.

The CHMP positive opinion is currently under review of the European Commission (EC) which has the authority to make a final decision on approval.

“With no centrally approved treatment option currently available in the EU, this positive opinion marks a significant milestone for the vitiligo community,” Incyte’s ( INCY ) Chief Medical Officer Steven Stein.

In January, Seeking Alpha contributor Denis Buivolov argued that the EU approval of Opzelura will be the company's second most important growth driver.

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