The FDA Has Approved The First Topical Treatment For Vitiligo

• Opzelura (ruxolitinib) has been licensed by the US Food and Drug Administration as the first treatment for nonsegmental vitiligo.

• For patients 12 years of age and older, the 1.5 percent cream is approved for twice-daily topical application to damaged areas covering up to 10% of the body surface area.

• More than 24 weeks of treatment may be required for satisfactory patient response.

• The TRuE-V clinical studies, in which over 600 patients were randomly assigned to Opzelura or placebo, would be used to support the approval.

• The face Vitiligo Area Scoring Index (F-VASI75) showed a 75 percent improvement from baseline in 30% of Opzelura-treated individuals at week 24, compared to 8 to 13% of placebo-treated participants.

• At week 52, over half of the Opzelura-treated individuals had F-VASI75.

 

Opzelura (ruxolitinib) Is The First Approved Treatment For Nonsegmental Vitiligo

• The Food and Drug Administration has approved a first-of-its-kind medication for vitiligo, a skin ailment that creates patches of discoloration and currently has few treatment choices.

 

Study’s Step For Opzelura

• The medication, known as ruxolitinib, is now the only one approved in the United States to treat vitiligo lesions in adults with the most prevalent type of vitiligo, known as "nonsegmental." 

• The FDA's decision, according to Incyte, the Delaware-based firm that developed ruxolitinib, was based on two clinical trials that recruited a few hundred individuals each and demonstrated the medicine dramatically improved repigmentation in the face and body.

 

Opzelura And Jakafi

• Ruxolitinib was created by Incyte as a topical cream for the treatment of vitiligo, and it will be marketed as Opzelura.

• Jakafi, an oral version of the medicine, has been on the market in the United States for over a decade, approved for use in a couple of bone marrow illnesses and a condition that can emerge after a patient undergoes a stem cell transplant.

 

How does Opzelura Works?

• Ruxolitinib inhibits a type of immune system-regulating protein known as a JAK, and drug agencies have recently raised concerns about the safety of JAK inhibitors created by Pfizer, Eli Lilly, and others.

 

Opzelura Cream Price For Vitiligo

• Opzelura topical cream 1.5 percent costs roughly $2,063 for 60 grams, depending on the pharmacy.