Incyte trial reveals encouraging results for patients with vitiligo

pharmafile | October 7, 2021 | News story | Business Services  

Incyte has announced full results from its Phase III TRuE-V Program, evaluating Ruxolitinib Cream in patients with vitiligo. Treatment with Opzelura was found to result in facial repigmentation at week 24. A significant proportion of patients treated with ruxolitinib cream achieved a higher than 50% improvement from baseline in total body Vitiligo Area Scoring Index (T-VASI50).

New findings from the week 24 analysis showed treatment with 1.5% ruxolitinib cream twice daily resulted in greater achievement of the primary endpoints and all key secondary endpoints, in both the TRuE-V1 and TRuE-V2 studies. Results were consistent across both studies.

These data were presented at the European Academy of Dermatology and Venereology (EADV) 30th Congress.

Opzelura was approved by the FDA for the treatment of atopic dermatitis in September 2021. Incyte now plans to submit a marketing application to the FDA and EMA, for the use of ruxolitinib cream for the treatment of adolescent and adult patients aged 12 and older who have vitiligo.

Vitiligo is a chronic autoimmune disease, characterized by the depigmentation of skin caused by the loss of pigment-producing cells, known as melanocytes. It affects approximately 0.5% to 2.0% of the population globally, and as it stands, there are no US FDA or EMA approved drug therapies for the treatment of vitiligo. The commercialisation of Opzelura is therefore promising for patients.

“The skin depigmentation associated with vitiligo can have a profound impact on a person’s life and patients are in need of additional treatment options,” said David Rosmarin, MD, Vice Chair of Research and Education, Dermatology Department at Tufts Medical Center. “I am extremely encouraged about the potential of ruxolitinib cream, as evidenced by the clinically meaningful improvements in repigmentation shown in the pivotal trials, and the potential benefits it may bring for my patients.”

Lina Adams


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