Hervé Hoppenot, Incyte CEO (Jeff Rumans for Endpoints News)

In­cyte nabs sec­ond ap­proval with JAK in­hibitor cream for vi­tili­go

Fol­low­ing a three-month de­lay, the FDA has ap­proved In­cyte’s JAK in­hibitor Opzelu­ra for a sec­ond in­di­ca­tion: vi­tili­go.

With the new ap­proval, Opzelu­ra be­comes the first repig­men­ta­tion cream ap­proved for vi­tili­go, an au­toim­mune dis­ease that caus­es patch­es of lost skin pig­men­ta­tion and im­pacts mil­lions — es­ti­mates for the US hov­er around 1% of the pop­u­la­tion, ac­cord­ing to one study.

The ap­proval comes on the back of two Phase III tri­als that en­rolled around 600 pa­tients over the age of 12. Af­ter 24 weeks, al­most one third of pa­tients met the pri­ma­ry end­point — at least a 75% im­prove­ment in their vi­tili­go area score — com­pared to 8-13% of pa­tients treat­ed with a place­bo cream. In an ex­tend­ed tri­al to one year, that fig­ure grew to about half the pa­tients in the study.

Endpoints News

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