The first topical JAK inhibitor cream, Opzelura, has been approved by the U.S. Food and Drug Administration for treating vitiligo in individuals 12 and older.
According to a study, 1.9 million to 2.8 million adult Americans have vitiligo, an autoimmune disorder brought on by antibodies that destroy the body’s pigment-producing cells. Patches of skin become nearly chalk white and lose pigment as a result.
“There’s a large unmet medical need here in vitiligo,” said Dr. Steven Stein, Chief Medical Officer at Incyte. “This opens a completely new door, a new avenue for them and for patients who want therapy to re-pigment.”
“With the approval of Opzelura in nonsegmental vitiligo, Incyte has once again delivered a treatment to patients with high unmet medical need who previously had no approved therapies,” Hervé Hoppenot, Incyte’s chief executive officer, said. “We are proud of Incyte’s scientists and development teams that have made this milestone possible, and we’re pleased that eligible vitiligo patients now have a choice to address repigmentation.”
Although the discoloration often doesn’t pose a health concern, it can lead to physical problems like severe sunburn, eye problems, and hearing loss. Dealing with others’ reactions might be difficult as well.
“Growing up with vitiligo has been pretty hard. Going around people seeing you with white patches. It’s very stressful that people judge you from your skin,” said Berardo Rivas, who has vitiligo. “It was traumatizing growing up.”
“My wife looked at me. She stared at me and said, you know, you have pigment back on your eyes, and I was like, I didn’t believe her. So I ran straight to the mirror. When I saw it, I was just jumping with joy. It’s like, oh, it’s working. You know, thank God.”
Doctors told ABC News that Vitiligo is challenging to manage and incurable. Before this FDA approval, oral and topical steroids were frequently used to treat vitiligo, but most of them are not long-term fixes.
Dr. Mansha Sethi, a board-certified dermatologist in Houston, said, “Since long-term use of steroids has a lot of side effects, dermatologists are always looking for steroid-sparing agents.”
“Emerging topical JAK-inhibitors, like Ruxolitinib (Opzelura), are a promising option,” Sethi said. “I personally have used JAK inhibitors off-label for several patients with vitiligo. Since it’s off-label, patients have to spend hundreds of dollars out of pocket to buy them from compounding pharmacies.”
However, upon FDA clearance, insurance companies are anticipated to start paying for this prescription medication.
Depending on your plan, it can be challenging to estimate how much the drug will cost. However, Incyte intends to “provide copay cards that will limit the out-of-pocket cost to patients to hopefully as little as $10 or less,” according to Dr. Stein. Additionally, the company’s IncyteCARES program may be used by individuals to receive Opzelura for free.
The Opzelura vitiligo research trials’ primary investigator, Dr. David Rosmarin, head of Tufts’ Clinical Trials Unit, told ABC News that he began looking for more effective therapies in 2013.
“We realized that the immune system is too active destroying the pigment cells,” he said.
A JAK1/JAK2 inhibitor explicitly targets vitiligo-related immune system pathways.
Over 600 men and women aged 12 and older took part in two Phase 3 clinical trials of Opzelura.
Results of the trial showed that “Adolescent and adult patients with vitiligo achieved substantial facial and total body repigmentation within 24 to 52 weeks of therapy.”
Using the study’s repigmentation measurement, half of all participants had a 75 % improvement in their facial vitiligo after a year.
According to Rosmarin, the adverse effects were manageable.
“Six percent of patients will get some acne, which is usually mild. And about 6% can have an application site reaction, which could be some redness,” Rosmarin said. “It has a very favorable safety profile, topical easy to use, and has proven to work very consistently.”
The medication needs to be prescribed and is administered twice daily as a cream to clean skin on vitiligo-affected areas.
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