Incyte reported positive results from a ruxolitinib cream (Opzelura) study in children 2-12 with atopic dermatitis (AD).
The study showed significantly more patients treated with ruxolitinib cream met the goal than those using a non-medicated cream.
The long-term safety portion of the study will continue as planned.
“AD is a chronic, immune-mediated skin condition that affects about 13% of all children in the U.S. It can cause disruptive symptoms like redness, dry skin and intense itch, which can detrimentally impact quality of life and be difficult to manage for both the child and their caregivers,” said Jim Lee, M.D., group vice president, Inflammation & AutoImmunity at Incyte. “We have already seen the benefit that ruxolitinib cream can have among adult and adolescent patients with atopic dermatitis in the TRuE-AD1 and TRuE-AD2 studies, and this new positive data reinforces the potential of ruxolitinib cream to offer children a much-needed effective, non-steroidal topical therapy. We look forward to discussing these data with regulatory agencies to determine next steps.”
Data from TRuE-AD3 will be submitted for presentation at an upcoming scientific meeting.
AD – the most common type of eczema – is a chronic skin disease in the U.S. that affects an estimated two to three million patients ages 2-11 and more than 21 million people 12 years and older. It is characterized by inflammation and itch. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and form a crust. AD patients are also more susceptible to bacterial, viral and fungal infections.
Opzelura, a cream formulation of Incyte’s JAK1/JAK2 inhibitor ruxolitinib, is approved by the U.S. Food & Drug Administration for the topical treatment of nonsegmental vitiligo in patients 12 years of age and older, is the first and only treatment for regaining skin pigment approved for use in the United States.
The cream is an offshoot of Incyte’s blockbuster blood cancer drug Jakafi.
Opzelura is also approved in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in many patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
The company has launched an advertising camapign for Opzelura aimed at those suffering from vitiligo.
Incyte is based near Wilmington.
Incyte’s share price was up 1.5% in Tuesday trading. Its share price has dropped more than 20% in the past six months over over concerns about earnings and drug pipeline.