The European Commission (EC) has approved Pfizer’s Cibinqo (abrocitinib) to treat moderate-to-severe atopic dermatitis (AD) adult patients.
The 100mg and 200mg doses of the oral small molecule drug are indicated to treat AD adult patients, who are systemic therapy candidates.
In addition, the regulator approved a 50mg dose of Cibinqo for the treatment of moderate-to-severe AD patients with kidney failure or patients being treated with cytochrome P450 (CYP) 2C19 inhibitors.
The drug selectively hinders Janus kinase (JAK) 1, to modulate multiple cytokines which are involved in pathophysiology of AD, including thymic stromal lymphopoietin (TSLP), interleukin IL-4, IL-13, IL-31, and IL-22.
The EC approval was based on the data obtained from five clinical trials, including four Phase III trials as well as an ongoing long-term open label extension trial. These trials were conducted on more than 2,800 patients.
In the clinical studies, the oral small molecule drug has showed improvements across disease control and symptom relief, compared to placebo.
Pfizer inflammation and immunology global president Mike Gladstone said: “There have been few treatment innovations over the last decade for those in the European Union suffering with the daily discomfort, distress, and pain caused by moderate-to-severe atopic dermatitis.
“The safety and efficacy established through a rigorous clinical trial program, designed to evaluate measures of symptom relief most important to patients, gives us great confidence in the positive impact Cibinqo could have on those living with this debilitating immuno-inflammatory condition.”
The company stated that the 200mg dose of Cibinqo showed superior improvement in itch relief after two weeks of treatment, in a trail that compared the drug with dupilumab.
Additionally, the drug showed a consistent safety profile along with a favourable benefit-risk profile across the studies.
Earlier this year, Cibinqo has also been authorised by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Korea’s Ministry of Food and Drug Safety (MFDS) and Japan’s Ministry of Health, Labour and Welfare (MHLW).