Incyte’s Opzelura gets MHRA authorisation

Therapy involves the treatment of non-segmental vitiligo among adults and adolescents

Incyte’s Opzelura gets MHRA authorization I QUANTUNG Pharma

Incyte Biosciences has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for Opzelura cream.

The therapy – also known as ruxolitinib – is indicated for the treatment of non-segmental vitiligo with facial involvement in adults and adolescents from 12 years of age upwards. Opzelura is the first approved treatment in the UK to offer an option for eligible patients with non-segmental vitiligo. The MHRA’s verdict arrives after the European Commission approved it earlier in the year.

The decision was based on data from two pivotal phase 3 clinical trials – TRuE-V1 and TRuE-V2 – which analysed the efficacy and safety of ruxolitinib cream versus a non-medicated cream. Over 600 individuals with non-segmental vitiligo aged 12 years and older participated in the studies.

Results duly demonstrated that treatment with ruxolitinib cream resulted in significant improvements in facial and total body repigmentation compared to the non-medicated cream. Meanwhile, there were no serious treatment-related adverse events related to ruxolitinib cream and the most prevalent adverse reaction was acne.

Emma Rush, founder and chief executive officer at Vitiligo Support UK, was positive about the authorisation: “While more and more people are proud of their vitiligo, there are still so many people who don’t feel comfortable in their skin. This new treatment option provides a choice for those who wish to treat their condition.”

Peter Williams, general manager, Incyte UK and Ireland, added: “We are delighted to announce the MHRA approval of Opzelura for people living with non-segmental vitiligo with facial involvement. We are now working in partnership with the NHS to ensure that eligible patients seeking to treat their vitiligo are able to access this innovative medicine.”

Dr Viktoria Eleftheriadou, consultant dermatologist and lead at Vitiligo Clinic and Research, Walsall Healthcare NHS Trust and the Royal Wolverhampton NHS Trust, concluded: “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.”

Vitiligo is a chronic autoimmune disease in which areas of skin depigment or lose their colour due the progressive destruction of pigment-producing cells known as melanocytes. About one in 100 people in the UK develop vitiligo, with approximately eight in ten patients suffering from non-segmental vitiligo. This occurs when both sides of the body are impacted by symmetrical white patches.