The FDA has approved Incyte’s (NSDQ:INCY) ruxolitinib, a cream for short-term and non-continuous chronic treatment of mild-to-moderate atopic dermatitis (eczema). As many as 15 million Americans have atopic dermatitis, according to the Cleveland Clinic. In addition, the NIH estimates that the condition affects 30 million Americans, predominantly children and adolescents.
The labeling for ruxolitinib (Opzelura) constrains its use to “non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.”
“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 Dr. Jonathan Silverberg, an associate professor of dermatology and director of clinical research and contact dermatitis at George Washington University, in a statement. “As a clinician, I am excited to have a non-steroidal topical cream like Opzelura.”
Opzelura will be the first topical Janus kinase (JAK) inhibitor on the U.S. market.
Earlier this month, FDA released a safety communication related to the risk of cardiovascular events associated with the JAK inhibitors Xeljanz and Xeljanz XR (tofacitinib) from Pfizer, Olumiant (baricitinib) from Eli Lilly, and Rinvoq (upadacitinib) from AbbVie.
The label for Opzelura will also carry a boxed warning describing the drug’s potential association with serious infection and cardiovascular events.
This is not the first time that FDA has approved a ruxolitinib-based drug. The agency approved an oral form of the medicine for intermediate or high-risk myelofibrosis in 2011. FDA later expanded indications to include polycythemia vera and steroid-refractory acute graft-versus-host disease.
Following releasing the FDA approval news, INCY stock has fallen. Today, investors reacted by sending INCY shares down 8.51% to $69.59 apiece.
Filed Under: Dermatology
