The US Food and Drug Administration (FDA) has approved Opzelura, also known as Ruxolitinib 1.5%, as an effective topical treatment for chronic vitiligo, according to a statement by Incyte, the drug’s manufacturer.
Vitiligo is a chronic disease, which leads to the loss of pigment in some areas on the skin and turning them into a milky white color. Ruxolitinib is the first drug that can restore pigment to the skin, in both adult and pediatric patients 12 years of age and older.
The US Food and Drug Administration (FDA) based its approval of this cream on the results of studies of more than 600 people (ages 12 and older) with vitiligo, which were done using an instrument to measure disease severity and to measure improvements in re-pigmentation. face and body.
The results were promising. After 24 weeks of treatment with the cream, a significant improvement in the re-pigmentation process of the skin was seen by up to 75% in the areas of vitiligo.
Dr. Daniel Gutierrez, MD, an assistant professor of dermatology at New York University, added that this approval is a very important co-development for drug development; Opzelura cream would be an effective treatment option to restore color to patients suffering from Vitiligo.
Usually, dermatologists sometimes prescribe topical corticosteroids for vitiligo patients, but there are risks when applying these medicines to the face, as they may cause an acne-like rash that can last for several months, called perioral dermatitis.
In addition, topical steroids can also cause changes in skin color and the appearance of stretch marks, and it has been noted that Ruxolitinib cream does not pose these risks to the skin.
Ruxolitinib cream belongs to a class of drugs called Janus kinase inhibitors, which work by decreasing the activity of the immune system, blocking certain enzymes that cause inflammation.
So far, the recommended dose of Opzelura Cream is twice daily on the areas affected by vitiligo, this may be to cover about 10% of the body surface area, and treatment may take 24 weeks or more for people with vitiligo to see positive and effective results.
Despite the many advantages of this cream, on the other hand, there are some common side effects seen in trials when using Opzelura cream: acne at the application site, redness, itching, inflammation of the pharynx and nasal cavity, headache, and urinary tract infection , and fever.
The FDA also added an important warning for people who take oral Janus kinase (JAK) inhibitors, because they may face a slightly increased risk of serious infections, major heart problems, thrombosis (blood clots), cancer, and even death. .
Although the same risks have not been seen in clinical trial results for people who use the cream topically; Because blood concentrations of the drug are much lower compared to people who take Ruxolitinib by mouth, the Food and Drug Administration (FDA) should caution against this.
The current price for a 60-gram tube of Opzelura cream is $1,950, according to Gabriella Gregg, an Incyte spokeswoman, but she also emphasized that the actual cost to the consumer will vary depending on the product’s insurance coverage and the amount of cream required for treatment.