Incyte’s Opzelura Meets Primary Endpoint in Eczema Trial, but Safety Concerns Persist

Incyte is attempting to enter the competitive market for atopic dermatitis with its JAK inhibitor cream, Opzelura, by targeting younger patients. While a recent successful outcome in a crucial trial indicates favorable prospects for the company’s objective, safety concerns may pose challenges in an upcoming market battle.

Opzelura demonstrated significant improvement in skin clearance compared to a non-medicated topical control in a phase 3 study for atopic dermatitis among children aged 2 to 11. The approved usage for the medication, a topical form of ruxolitinib (an active component in Jakafi), is in eczema patients aged 12 and above.

Patients who received Opzelura in the TRuE-AD3 study were more likely to achieve clear skin by week eight, as assessed by a two-point increase in the Investigators’ Global Assessment of Treatment Success (IGA-TS) score. Thus, the experiment successfully achieved its primary objective.

This news follows Dermavant, a division of Roivant Sciences, reporting success in two phase 3 studies for atopic dermatitis in children as young as 2. Additionally, Arcutis Biotherapeutics recently announced success with its Zoryve cream in two phase 3 studies for children aged 6 and older suffering from eczema, with topline results from another study in children aged 2 to 5 expected later this year.

For Opzelura, the burden of a JAK class-wide boxed warning could prove to be too much.

The FDA included a boxed warning on the label of Opzelura in 2021 when approving it for eczema treatment. The warning outlines severe infections, increased risks of cardiovascular disease, and other adverse effects observed in studies with oral JAK inhibitors.

Opzelura consists of 1.5% ruxolitinib and is administered twice daily, originally approved for use in patients aged twelve or older. Incyte evaluated both this dosage and a weaker 0.75% strength during the TRuE-AD3 study in younger patients.

The company did not release specific figures regarding the drug’s effectiveness or safety, but it stated that the safety profile is “consistent with previous data” and no “new safety signals” were observed. The study is still ongoing to gather long-term safety information.

Jim Lee, M.D., Incyte’s VP for inflammation and autoimmunity, mentioned in a statement on Wednesday that the company will engage with regulatory bodies to examine the findings and identify future measures. The company estimates that between 2 and 3 million children between the ages of 2 and 11, and over 21 million individuals over the age of 12, suffer from eczema worldwide.

In the meantime, Opzelura might benefit from market expansion. Sales of the drug were disappointing in the first quarter, totaling $57 million, a sequential decrease of 8%. At that time, analysts at Leerink Partners believed that Vtama and Zoryve would enter the eczema market in late 2024. Neither of these drugs requires a boxed warning for plaque psoriasis.

Incyte is also grappling with a high Opzelura discount rate – 50% to 60% as of the beginning of the quarter. The Leerink team speculates that payers may leverage the threat of competition to negotiate even greater discounts.

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