The U.S. Food and Drug Administration has approved Opzelura (ruxolitinib) cream for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis (AT).
The cream is approved for patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
Incyte is based near Wilmington.
The cream is in the same class of drugs as Incyte’s blockbuster Jakafi blood cancer 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 disease,” said Jonathan Silverberg, M.D., associate professor of Dermatology and Director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine and Health Sciences. “As a clinician, I am excited to have a non-steroidal topical cream like Opzelura.”
“The approval of Opzelurais an important advancement in the treatment of AD, and we are pleased to offer a novel topical treatment option that targets a pathway believed to be a source of inflammation,” said Hervé Hoppenot, CEO of Incyte. “At Incyte, we are committed to transforming the treatment of immune-mediated dermatologic conditions like AD. We look forward to bringing Opzelurato the patient community and also continuing to explore its potential in other challenging skin diseases.”
The approval came after late-stage studies with teens and adults with mild to moderate cases.
The studies showed patients experienced significantly clearer skin and itch reduction when treated with Opzelura cream twice daily.
In clinical trials, adverse reactions were greater or equal to 1 percent of those in the trial.
AD is a chronic skin disease affecting more than 21 million people aged 12 years and older in the U.S. and is characterized by inflammation and itch3. Signs and symptoms include irritated and itchy skin that can cause red lesions that may ooze and crust. People with AD are also more susceptible to bacterial, viral, and fungal infections.
Financial assistance may be available for those who cannot afford the medication. Information is available at www.incytecares.com or by calling 1-855-452-5234, Monday through Friday, from 8 a.m. to 8 p.m. Eastern.