As Incyte Corporation’s recently-minted Opzelura gets off to the races in eczema, the drug has run up against a setback in another dermatology indication.
The FDA has delayed its decision on Incyte’s drug in vitiligo by three months. The regulator now plans to deliver a verdict on the topical JAK inhibitor, also known as ruxolitinib cream, by July 18, Incyte said in a release.
The FDA will use the extra time to review additional data from Opzelura’s ongoing phase 3 studies, which the regulator previously requested from Incyte. The FDA has flagged the additional information from Incyte as a “major amendment” to its vitiligo application, leading to the action date extension, the company said.
“We are confident in the data from the TRuE-V clinical trial program which supports our sNDA submission for ruxolitinib cream in vitiligo, and we look forward to bringing this innovative topical treatment to patients with vitiligo in the United States for whom there are no approved therapies that address repigmentation,” Steven Stein, M.D., Incyte’s chief medical officer, said in Monday’s release.
The company’s late-stage TRuE-V clinical program, which includes the studies TRuE-V1 and TRuE-V2, is assessing Opzelura in more than 600 patients ages 12 and older with non-segmental vitiligo.
It’s unknown exactly what sort of additional information the FDA has requested from Incyte, but the move doesn’t seem “indicative of a major concern given Opzelura is continuing its launch in atopic dermatitis (AD), and all [chemistry, manufacturing and controls] issues should have been addressed during the AD review,” SVB Leerink analysts wrote in a note to clients Monday.
The analysts figure the delay is “temporary and more procedural in nature versus substantive,” as the FDA could have handed down a complete response letter if it saw a reason to reject Opzelura’s vitiligo application.
Still, a vitiligo nod would represent just a small portion of Opzelura sales, worth about $182 million in peak U.S. revenues, the SVB Leerink team predicts.
Opzelura, a sister med to Incyte’s Jakafi, is already well on its way to a vitiligo green light in Europe. In late October, regulators validated the medicine's European Marketing Authorization Application, meaning the submission was ready to enter the formal review process, Incyte said at the time.
In December, meanwhile, the U.S. FDA accepted Opzelura’s vitiligo application for priority review, setting an original action date of April 18.
Vitiligo is a chronic autoimmune disease that leads to the depigmentation of skin from the loss of pigment-producing cells known as melanocytes, Incyte has said. The condition is estimated to affect more than 1.5 million people in the U.S., and there are currently no FDA or EMA-approved therapies for repigmentation in vitiligo.
“Over-activity of the JAK signaling pathway is believed to drive inflammation involved in the pathogenesis and progression of vitiligo,” the company said in last year’s priority review announcement.
Opzelura’s U.S. vitiligo delay follows an FDA approval in mild to moderate atopic dermatitis in September. Specifically, the drug is cleared to treat eczema patients 12 and older who aren’t suitable for or have failed on other topical prescription meds.
The drug’s green light came with a classwide black box warning that’s been added to oral JAKs about serious infections, death, cancer, heart-related events and blood clots. Despite those boxed warnings, Incyte thinks Opzelura could reach at least $1.5 billion in peak sales, executives said on an investor call last year.
Last month, Incyte CEO Hervé Hoppenot trumpeted Opzelura's “very successful" launch in atopic dermatitis. After an official rollout in mid-October, the topical med reached nearly 19,000 patients in the fourth quarter, which translated into $5 million in sales, the CEO said.
Editor's note: This story was updated with analyst comments.