Pfizer Inc. (NYSE: PFE) today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Great Britain marketing authorization for CIBINQO® (abrocitinib), an oral, once-daily, Janus kinase 1 (JAK1) inhibitor, for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents aged 12 years and over, who are candidates for systemic therapy. Abrocitinib is licensed in Great Britain in recommended doses of 100mg and 200mg. This is the first marketing authorization worldwide for this treatment.
"We welcome the MHRA's authorization of abrocitinib to treat people with moderate to severe atopic dermatitis. This is an important development for people in Great Britain who have moderate to severe disease and need innovative treatment options," said Angela Hwang, Group President, Pfizer Biopharmaceuticals Group. "Following marketing authorization, our priority now is to work with NICE and the Scottish Medicines Consortium (SMC) to ensure routine access so that patients with moderate to severe AD can benefit from this important treatment."
Last year, abrocitinib received a Promising Innovative Medicine (PIM) designation from the MHRA. In January of this year, abrocitinib was granted a positive scientific opinion for an Early Access to Medicines Scheme (EAMS) from the MHRA for people with severe atopic dermatitis requiring treatment with systemic therapy and who have had inadequate response or have lost response to licensed systemic therapies, or who are ineligible or intolerant of licensed systemic therapies. This enabled healthcare professionals to prescribe the treatment prior to marketing authorization, based on clinical factors for patients with a clear unmet need.
Regulatory applications for abrocitinib have been submitted to countries around the world for review, including the United States, Australia, Japan, and the European Union.
About Atopic Dermatitis
AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects.i,ii Lesions of AD are characterized by erythema (skin turning red or purple depending on normal skin color), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting.ii,iii
AD is one of the most common, chronic, relapsing childhood dermatoses, affecting up to 10% of adults and up to 20% of children worldwide.iii,iv AD is the most common chronic inflammatory skin disease in the UK,v affecting approximately 20% of children and 10% of adults.vi
About CIBINQO® (abrocitinib)
CIBINQO (abrocitinib) is an oral small molecule that selectively inhibits Janus kinase (JAK) 1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD, including interleukin IL-4, IL-13, IL-31, IL-22, and thymic stromal lymphopoietin (TSLP).vii
SAFETY INFORMATION
A total of 3,128 patients were treated with CIBINQO in clinical studies in atopic dermatitis. There were 994 patients with at least 48 weeks of exposure. Five placebo‑controlled studies were integrated (703 patients on 100mg once daily, 684 patients on 200mg once daily and 438 patients on placebo) to evaluate the safety of CIBINQO in comparison to placebo for up to 16 weeks.
The most commonly reported adverse reactions occurring in ≥ 2% of patients treated with CIBINQO 200mg in placebo-controlled studies are: nausea (15.1%), headache (7.9%), acne (4.8%), herpes simplex (4.2%), blood creatine phosphokinase increased (3.8%), vomiting (3.5%), dizziness (3.4%) and abdominal pain upper (2.2%). The most frequent serious adverse reactions are infections (0.3%).
