Incyte wins ‘historic’ FDA approval for vitiligo drug

The U.S. Food and Drug Administration has approved Incyte’s Opzelura as its first treatment of vitiligo. | PHOTO COURTESY OF INCYTE

WILMINGTON – Incyte secured on Monday the first U.S. Food & Drug Administration approval for a treatment of the skin pigmentation disorder vitiligo, demonstrating the growing strength of the biopharmaceutical company’s dermatological products after starting with cancer treatments.

Headquartered near Wilmington and employing more than 1,000 people in Delaware, Incyte is best known for its blockbuster small-molecule drug Jakafi that is used in the treatment of rare bone marrow cancer, blood diseases and in certain bone marrow donations. Last year, sales and royalties from Jakafi totaled more than $2.4 billion, or more than 80% of the company’s revenues.

In its research for new cancer drugs, Incyte researchers discovered that Jakafi, known generically as ruxolitinib, was effective in treating non-cancer, autoimmune diseases, including vitiligo and eczema. Last year, it won FDA approval for Opzelura for eczema in some patients and actively sought to secure approval for vitiligo.

Vitiligo is an autoimmune disease that causes patches of skin depigmentation . | PHOTO COURTESY OF INCYTE

The disease causes skin to lose its color in patches that usually get bigger with time. It occurs when the cells that produce the pigment melanin die or stop functioning properly. While it affects people of all skin types, it’s often most noticeable and stigmatizing in the Black community, where the patches are more visible. Although not life-threatening or contagious, there is no cure for vitiligo.

After a yearlong study of Opzelura, the results for vitiligo were stunningly effective, with few adverse reactions to the medication, and roughly 86% of patients seeing some improvement within a year, and 30% seeing dramatic improvements. Opzelura is approved for use in ages 12 and up with no limits on usage duration or areas of application – it’s non-steroidal which will benefit its application opportunity.

There are more than 1.5 million patients diagnosed with vitiligo in the U.S., with upward of 200,000 currently actively seeking treatment without an FDA-approved drug, and another more than 2 million patients in Europe. In preparation for the commercial rollout of Opzelura for vitiligo, Incyte has already signed contracts with the three largest pharmacy benefit managers (PBMs) and group purchasing organizations (GPOs) that cover 80% of the end market, officials said.

Incyte CEO Herve Hoppenot addresses the crowd at the ribbon cutting for the company’s new Wilmington lab in April. | DBT PHOTO BY JACOB OWENS

“Opzelura has the potential to be a substantial growth driver for Incyte,” CEO Hervé Hoppenot told investors Tuesday morning.

Dr. Seemal Desai, a clinical assistant professor at the University of Texas Southwestern Medical Center and a practicing dermatologist, who participated in the study of Opzelura, called it a “historic step” in the treatment of vitiligo. He noted that he has long had to prescribe off-label treatments, but the FDA-cleared drug would be a “game-changer.”

“Patients have been waiting a very long time for an FDA-approved therapy that actually delivers results that has a scientific basis and mechanism with the JAK-STAT inhibition of actually managing their disease. So, I couldn’t be more excited about this,” Desai said, noting that vitiligo also impacts patients psychologically.

Vitiligo affects 1% to 3% of the combined American and European population and affects both sexes equally. Many patients see their first depigmentation before the age of 20. A stigmatizing disease, vitiligo patients report depression at a rate five times higher than those without, according to Incyte’s presentation.

The FDA approval of Opzelura for vitiligo will start a full-scale commercial roll-out and marketing campaign within a few months, but Incyte is also eyeing European approval for vitiligo treatment for as early as the end of this year.