The label expansion of CIBINQO was supported by the data from the phase 3 JADE TEEN clinical trial which evaluated the 100mg and 200mg doses of CIBINQO versus placebo
The US FDA has expanded the indication for Pfizer’s CIBINQO to include adolescents. (Credit: Pfizer Inc.)
Pfizer has secured approval from the US Food and Drug Administration (FDA) for its supplemental new drug application (sNDA) to expand the indication of CIBINQO (abrocitinib) to cover the treatment of a type of atopic dermatitis (AD) in adolescents.
CIBINQO can be used in the US now for 12- to 18-year-olds having refractory, moderate-to-severe atopic dermatitis, for whom, other systemic drugs were ineffective, or the use of those therapies is not advisable.
The drug was previously approved to treat atopic dermatitis in adults aged 18 years and above.
CIBINQO is designed to be an oral inhibitor of Janus kinase (JAK) 1 inhibitor for modulating multiple cytokines that are involved in the pathophysiology of the skin condition.
The label expansion of CIBINQO to cover adolescents was supported by the data from the placebo-controlled, randomised phase 3 JADE TEEN clinical trial.
According to the pharmaceutical firm, the trial assessed both the 100mg and 200mg doses of the Pfizer drug compared to placebo in 285 adolescents with moderate-to-severe atopic dermatitis of the 12 to 18 years age group, while on background topical therapy.
According to the findings of the study, 39% and 46% of patients treated with CIBINQO 100mg and 200mg, respectively, had an Investigator Global Assessment (IGA) 0 or 1 response, as compared to 24% of patients who received a placebo.
At week 12, compared to 41% of patients treated with a placebo, 71% and 64% of patients treated with the two doses of CIBINQO, had an Eczema Area and Severity Index (EASI)-75 response.
Additionally, the oral inhibitor showed a consistent safety profile and significant improvements in skin clearance, degree of illness, and severity as well as a quick relief of itching after two weeks.
Pfizer global biopharmaceuticals business chief commercial officer and president Angela Hwang said: “Moderate-to-severe atopic dermatitis can have debilitating physical and emotional impacts on adolescents.
“As an efficacious once-daily pill, we believe that Cibinqo offers an important new treatment option for adolescents burdened by uncontrolled symptoms of atopic dermatitis.
“Encouraged by an increasing uptake in the adult population, we look forward to bringing this important new oral medicine to adolescents who have yet to find relief from this inflammatory skin condition with current options.”