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Home / Wellness / Skin and Beauty / FDA Approves First At-Home Topical Treatment for Vitiligo

FDA Approves First At-Home Topical Treatment for Vitiligo

covered by their insurance companies instead of having to pay hundreds of dollars out of pocket.

As for how much the medication will cost?

It’s difficult to predict how much the medication will cost depending on the plan you have, however, Incyte plans 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. The company also has a program that some may qualify to get Opzelura for free called IncyteCARES.

How did Opzelura perform in clinical trials?

The medication, which requires a prescription and is applied as a cream to clean skin on areas affected by vitiligo twice a day was tested in two Phase 3 clinical trials, which enrolled over 600 men and women ages 12 and older.

Results of the trial showed that “adolescent and adult patients with vitiligo achieved substantial facial and total body re-pigmentation within 24 to 52 weeks of therapy.”

Half of all participants had 75% improvement of their facial vitiligo after one year using the study’s measurement of repigmentation.

As for side effects, those seemed to be well tolerated among patients.

“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,” Dr. David Rosmarin, director of the Clinical Trials Unit at Tufts, and the principal investigator for the Opzelura vitiligo clinical trials shares. “It has a very favorable safety profile, topical easy to use, and has proven to work very consistently.”

Jim Lee, vice president for Incyte’s head inflammation and autoimmunity group, hopes that more doctors and patients will become aware of JAK inhibitors and more comfortable using them.

Combining the cream with other treatments, such as light therapy, to accelerate skin repigmentation may also be an option for vitiligo patients. Rosmarin says he is eager to explore these avenues in future clinical trials, and gain more knowledge on how JAK inhibitors can be used to treat other autoimmune diseases, which tend to appear in vitiligo patients.

July 20, 2022 by Cara Jones

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