Incyte Corporation (NASDAQ: INCY) has announced the US FDA has approved Opzelura cream for non-continuous and short-term chronic treatment for atopic dermatitis in non-immunocompromised patients above 12 years. In addition, Opezelura has been approved for patients whose disease has not to be controlled adequately with topical prescription treatments or when standard therapies are not appropriate.
Opzelura only JAK inhibitor approved in the US
Notably, the drug is the first and only JAK inhibitor topical formulation licensed in the US. According to research, dysregulation of the JAK-STAT pathway has been linked to critical aspects of Alzheimer’s disease, including itching, inflammation, and epidermal barrier failure.
Associate Professor of Dermatology and Director of Clinical Research and Contact Dermatitis at The George Washington University School of Medicine and Health Sciences Jonathan Silverberg said, “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. As a clinician, I am excited to have a non-steroidal topical cream like Opzelura.”
Opzelura tested in 1,200 adolescents
CEO Herve Hoppenot said, “The approval of Opzelura is 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. At Incyte, we are committed to transforming the treatment of immune-mediated dermatologic conditions like AD. We look forward to bringing Opzelura to the patient community and also continuing to explore its potential in other challenging skin diseases.”
The FDA granted the approval based on results from the TRuE-AD (Topical Ruxolitinib Evaluation in Atopic Dermatitis) clinical study program, which included two double-blind, randomized, vehicle-controlled Phase 3 trials (TRuE-AD1 and TRuE-AD 2) that assessed the safety and efficacy of Opzelura in over 1,200 adolescents and adults with mild to moderate AD. Patients treated with Opzelura cream 1.5% had much clearer skin and less itching.
