FDA Approves First Topical JAK Inhibitor for Atopic Dermatitis

The FDA granted a first-ever approval of a topical Janus kinase (JAK) inhibitor for atopic dermatitis (AD).

Ruxolitinib (Opzelura) cream received approval for short-term, noncontinuous treatment of moderate-to-severe AD that has not been adequately controlled with topical prescription therapies or the therapies are not advisable. The approval specifies use of ruxolitinib cream in non-immunocompromised patients ages 12 and older.

“Many patients do not respond well to existing treatments and have uncontrolled disease,” said Jonathan Silverberg, MD, PhD, MPH, of George Washington University School of Medicine and Health Sciences in Washington, D.C., in a statement from Incyte. “As a clinician, I am excited to have a nonsteroidal topical cream like Opzelura.”

Support for the approval came from the randomized, vehicle-controlled, phase III TRuE-AD1 and TRuE-AD2 clinical trials, which involved a combined total of more than 1,200 adults and adolescents with moderate-to-severe AD. Patients in both trials were randomized to twice-daily topical ruxolitinib or a non-medicated cream. The primary endpoint was Investigator’s Global Assessment (IGA) of Treatment Success at week 8 (IGA score 0/1).

More than half of patients randomized to ruxolitinib cream met the primary endpoint as compared with 15.1% and 7.6% of patients in the control groups (P<0.0001). Additionally, more than half of patients in the ruxolitinib groups had clinically meaningful reductions in itch versus 15-16% of patients randomized to vehicle (P<0.0001).

The most common treatment-emergent adverse events in ruxolitinib-treated patients were nasopharyngitis, diarrhea, bronchitis, ear infection, increased eosinophil count, urticaria, folliculitis, tonsillitis, and rhinorrhea.

“It can be hard for people to fully appreciate how difficult AD can be and the tremendous impact it has on patients,” said Julie Block, president and CEO of the National Eczema Association. “The chronic itch is difficult to cope with and related sleep issues can be exhausting. Many patients and their dermatologists are looking for additional options to meet current unmet needs in the management of AD. The approval of Opzelura is exciting news, and we welcome a new treatment option for our community.”

Last Updated September 22, 2021