Incyte Ends Rebate Dispute With U.S. Government, Nears $1.5 Billion Blockbuster Milestone

Incyte’s atopic dermatitis treatment Opzelura is nearing blockbuster status after resolving a regulatory issue with U.S. health authorities.

According to Fierce Pharma on the 29th (local time), Incyte raised its 2026 full-year sales forecast for Opzelura to between $1.05 billion (approximately 1.575 trillion won) and $1.1 billion (approximately 1.65 trillion won) after reaching a rebate-related agreement with the Centers for Medicare & Medicaid Services (CMS). The figure is substantially higher than the previous forecast of less than $800 million (approximately 1.2 trillion won).

The agreement was reached after CMS decided not to consider Opzelura an expansion of the Jakafi product family, an oral treatment for myelofibrosis. As a result, Incyte benefited from a one-time $246 million (approximately 369 billion won) increase in second-quarter revenue and expects an additional $40 million to $50 million (approximately 60 billion to 75 billion won) in profit by the end of this year.

Excluding the one-time benefit, second-quarter revenue was $204 million (approximately 306 billion won), up 24% from the same period a year earlier. Prescriptions in the United States increased 26%, while international revenue grew 34% to $43 million (approximately 64.5 billion won).

Incyte CEO Bill Meury said at the company’s earnings call on the 28th, “Because the pricing and reimbursement environment remains dynamic, maintaining broad access is our top priority.”

Opzelura’s growth is expected to receive further support. Recently, the European Commission (EC) approved Opzelura for the treatment of patients with moderate atopic dermatitis for whom topical corticosteroids and other treatments are ineffective. Results from a phase 3 trial in hidradenitis suppurativa (HS), expected by the end of this year, are also drawing attention. If successful, it could become the first topical treatment specifically indicated for HS.

Meanwhile, Incyte’s flagship product Jakafi generated second-quarter revenue of $817 million (approximately 1.2255 trillion won), up 7% year over year. The company recently received U.S. Food and Drug Administration (FDA) approval for Jakafi XR, an extended-release formulation that can be taken once daily, and aims to transition 10% to 30% of existing patients before the patent expires at the end of 2028.

The company expects FDA approval in the first quarter of 2027 for the next-generation JAK1 inhibitor povorcitinib for the treatment of hidradenitis suppurativa. In addition, it plans to report pivotal clinical results in prurigo nodularis this year.