FDA approves Cibinqo for moderate to severe atopic dermatitis
The FDA approved Cibinqo, an oral, once-daily JAK inhibitor, for the treatment of patients with moderate to severe atopic dermatitis, according to a press release.
Supported by safety and efficacy data across three randomized, placebo-controlled phase 3 trials, Cibinqo (abrocitinib, Pfizer) demonstrated a consistent safety profile and improved skin clearance, extent of disease severity and itch among 1,600 patients with atopic dermatitis compared with placebo. The FDA recommended a dose of 100 mg and 200 mg among lower dosage non-responders.
Additionally, they approved a 50 mg dose for patients with moderate renal impairment, certain patients receiving treatment with inhibitors of cytochrome P450 (CYP) 2C19 or patients who are known or suspected to be poor metabolizers of CYP2C19.
“The reality for patients living with chronic inflammatory skin disease such as moderate to severe atopic dermatitis is that many experience debilitating symptoms that are not managed by current treatment options,” Jonathan Silverberg, MD, PhD, MPH, of The George Washington University School of Medicine and Health Sciences, said in the release. “Today’s approval of Cibinqo will provide an important new oral option that could help those who have yet to find relief. In multiple large-scale clinical trials, Cibinqo demonstrated strong efficacy at clearing skin, improving itch, and managing the extent and severity of eczema, offering a benefit-risk profile that supports the use of this treatment in the FDA-approved patient population.”