MHRA grants marketing authorisation for a new treatment option for non-segmental vitiligo with facial involvement in adults and adolescents.
Following on our previous updates on the status of the marketing authorisation for ruxolitinib cream in the UK, we can confirm that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted approval for Opzelura (ruxolitinib) cream 15mg/g for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age in the UK.
Incyte issued a news release at the beginning of the month announcing this approval, which was welcomed by many people in our vitiligo community.
Dr. Viktoria Eleftheriadou, Consultant Dermatologist & Lead for Vitiligo Clinic and Research, Walsall Healthcare NHS Trust and The Royal Wolverhampton NHS Trust
Today’s MHRA approval is welcome news for dermatologists and people with vitiligo seeking treatment who until now have had limited options. The data supporting this approval demonstrate the potential for ruxolitinib cream to make a difference in the lives of people living with this condition.
You can read the full announcement here.
The treatment is currently going through the NICE (National Instituted for Health and Care Excellence) appraisal process to decide if the treatment can be made available via the National Health Service. Our Society is involved in this process and will continue to update our community via our Monthly Newsletter, and updates can also be found by visiting the NICE website here. A decision is currently expected March 2024.