Cibinqo (abrocitinib) is a once-daily oral JAK1 inhibitor indicated for the treatment of moderate to severe atopic dermatitis in patients aged 12 years and above
Pfizer has obtained the UK Medicines and Healthcare products Regulatory Agency (MHRA) marketing authorisation for Cibinqo (abrocitinib) to treat atopic dermatitis (AD).
Cibinqo is a once-daily oral JAK1 inhibitor, believed to modulate multiple cytokines involved in the pathophysiology of AD, including interleukins and thymic stromal lymphopoietin (TSLP).
The drug was indicated for the treatment of moderate to severe AD in patients aged 12 years and above, who are eligible for systemic therapy, in Great Britain.
The authorisation recommended 100mg and 200mg doses of the drug and is said to be the world’s first marketing authorisation for the treatment of AD.
Pfizer biopharmaceuticals group president Angela Hwang said: “We welcome the MHRA’s authorisation 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.
“Following marketing authorisation, 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.”
Cibinqo has received a Promising Innovative Medicine (PIM) designation from the MHRA, last year.
Also, it was granted a positive scientific opinion for an Early Access to Medicines Scheme (EAMS) from the MHRA, earlier this year.
The positive MHRA opinion enabled healthcare professionals to prescribe the treatment before marketing authorisation, based on clinical factors for patients with unmet needs.
The company has submitted regulatory applications to regulatory authorities in countries including the US, Australia, Japan, and the European Union (EU), for the review of Cibinqo.
AD is a chronic skin disease characterised by inflammation of the skin and skin barrier defects. Lesions of AD are characterised by erythema, itching, induration, and oozing.
It is the most common chronic inflammatory skin disease in the UK, and worldwide, affecting up to 10% of adults and up to 20% of children globally.