MHRA (UK) approves Opzelura cream to treat non-segmental vitiligo.- Incyte Biosciences.
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 III 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.
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