Previously approved by the authorities in the UK, Japan and South Korea, Cibinqo is an oral Janus kinase 1 (JAK 1) inhibitor that modulates multiple cytokines involved in pathophysiology of atopic dermatitis
Pfizer World Headquarters in Manhattan, New York. (Credit: Coolcaesar/Wikipedia.)
Pfizer has secured the European Commission (EC) approval for Cibinqo (abrocitinib) in 100mg and 200mg dose formulation, to treat a type of atopic dermatitis (AD).
The drug is indicated for adults with moderate-to-severe atopic dermatitis (AD), who are candidates for systemic therapy.
In addition, 50mg dose has also been approved to treat moderate-to-severe AD patients with kidney failure, or certain patients eligible for cytochrome P450 (CYP) 2C19 inhibitors.
Cibinqo is an oral small molecule that selectively targets Janus kinase 1 (JAK 1), to modulate multiple cytokines involved in pathophysiology of AD.
The drug was previously authorised by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), Japan’s Ministry of Health, Labour and Welfare (MHLW) and Korea’s Ministry of Food and Drug Safety (MFDS).
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 EC approval of Cibinqo was supported by results from five clinical trials, including four Phase 3 studies and an ongoing long-term open label extension study.
In the studies, involving more than 2,800 patients, Cibinqo showed meaningful improvements across symptom relief and disease control, compared to placebo.
In one of the trials that compared Cibinqo with dupilumab, Cibinqo 200mg showed superior improvement in itch relief after two weeks, compared to dupilumab.
Also, the drug showed a consistent safety profile across the studies, with a favourable benefit-risk profile, said Pfizer.
AD is a chronic inflammatory skin disease that affects up to 10% of adults worldwide, and is characterised by dry skin, intense itching and recurrent relapsing eczematous lesions.
The lesions are associated with erythema, induration, lichenification, oozing/crusting.
Christian-Albrechts University dermatology professor Stephan Weidinger said: “The approval of Cibinqo in the European Union makes me hopeful for many patients who will have this additional option to help manage the often painful and disruptive symptoms of moderate-to-severe atopic dermatitis.”