FDA approves first at-home therapy for vitiligo patients
Patients with vitiligo will now have access to the first ever at-home therapy for skin repigmentation approved by the Food and Drug Administration.
The FDA announced the approval of Incyte’s ruxolitinib cream on Monday based on data collected from two duplicate Phase 3 clinical trials that found 30% of patients using the cream regained 75% or more skin repigmentation on the face and roughly 20% of patients regained at least 50% or more repigmentation on their body after 24 weeks.
The 1.5 percent cream is approved for continuous topical use twice daily to affected areas of up to 10 percent of body surface area in patients aged 12 years and older. More than 24 weeks of treatment may be needed for satisfactory patient response.
Jim Lee, vice president for Incyte’s head inflammation and autoimmunity group, said before the approval of ruxolitinib, whose brand name is Opzelura, vitiligo patients were limited to light therapies administered in a doctor’s office. Now, they can administer a cream at home.
“It’s very exciting and quite an honor to be able to bring the first treatment option for these patients,” Lee said.
Vitiligo affects millions of people; an estimated 0.5% to 2% of the worldwide population has the autoimmune disorder