On July 18, 2022, the U.S. Food and Drug Administration (FDA) announced that they had approved the first drug to treat Vitiligo. This led to widespread confusion and false information being spread online. Some users claimed that the treatment was brand new, but it has been approved to treat a variety of skin problems since 2021. Users claimed that the drug could treat Vitiligo in general, but studies show that it can only treat non-segmental Vitiligo and not the more severe cases.
What Is Opzelura?
Opzelura is a JAK inhibitor topical cream used to treat moderate eczema. It has the ability to reduce itching and aid in skin clearing. Opzelura has been tested on people with various skin tones and can be applied to any area that has eczema, including sensitive areas like the face.
Is Opzelura a New or Old Drug?
Some social media users claimed that Opzelura is a new medication manufactured to cure vitiligo patients.
Misbar investigated the circulating claim and discovered it to be misleading.
The U.S. Food and Drug Administration (FDA) initially approved Opzelura as a cream on September 21, 2021, for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis. According to Opzelura's official website, the drug is not new.
The claim came after the U.S. Food and Drug Administration (FDA) approved Opzelura™ (ruxolitinib) cream 1.5% for the topical treatment of Vitiligo on July 18, 2022, for adult and pediatric patients 12 years of age and older.
Hervé Hoppenot, the CEO of Incyte, stated that the approval of Opzelura is an important advancement in the treatment of AD.
Jonathan Silverberg, M.D., Ph.D., M.P.H. and Director of Clinical Research and Contact Dermatitis, commented on the significance of the drug: “Atopic dermatitis is a chronic immune-mediated disease that can be challenging to manage. Many patients do not respond well to existing treatments and have uncontrolled diseases. As a clinician, I am excited to have a non-steroidal topical cream like Opzelura.”
Can Opzelura Cure All Types of Vitiligo?
After the FDA approved the drug in July 2022, social media users started circulating news that Opzelura could cure all types of Vitiligo.
However, according to the drug's official website, Opzelura can only treat non-segmental Vitiligo and not severe Vitiligo cases.
What Is Vitiligo?
Vitiligo is a chronic autoimmune disease featured by depigmentation of the skin. Opzelura is the first and only FDA-approved medication for repigmentation in patients with Vitiligo, and the only topical formulation of a Janus kinase (JAK) inhibitor approved in the United States.
Opzelura is licensed for continuous topical application twice daily to affected areas, covering up to 10% of the body surface area in patients with non-segmental Vitiligo. If the patient's response is satisfactory, Opzelura treatment may last for more than 24 weeks.
“With the approval of Opzelura in non-segmental Vitiligo, Incyte has once again delivered a treatment to patients with high unmet medical needs who previously had no approved therapies,” said Hervé Hoppenot, Chief Executive Officer, Incyte. “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.”
At week 24 across trials, 30% of Opzelura patients showed 75% improvement.
Opzelura May Have Serious Side Effects
Opzelura is a prescription-only medication that must be administered by a doctor. Opzelura may cause dangerous side effects in people with active, serious infections, especially localized infections. It has the potential to cause blood clots in the lungs or leg veins. Cancer and immune system disorders may develop as a result of the disruption of normal immune system function. It may increase the risk of serious cardiovascular problems, such as heart attacks and strokes.