The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved a marketing authorisation for Pfizer’s oral Janus Kinase 1 (JAK1) inhibitor Cibinqo (abrocitinib) for the treatment of moderate to severe atopic dermatitis – the most common form of eczema.
The authorisation clears Cibinqo to treat the common inflammatory skin disease in adults and adolescents aged 12 years and over who are candidates for systemic therapy.
In a statement, Pfizer noted that this is the first marketing authorisation in the world for Cibinqo.
Cibinqo has been evaluated as monotherapy and in combination with background medicated topical therapies over 12-16 weeks across three Phase III studies, which enrolled a total of 1,616 patients.
Across all three studies, a significantly larger proportion of patients achieved both primary endpoints Investigator Global Assessment (IGA) 0 or 1 and/or Eczema Area and Severity Index-75 (EASI-75) with 100mg or 200mg once daily Cibinqo compared with placebo at week 12 or week 16.
On top of that, significantly more Cibinqo-treated patients achieved at least a Peak Pruritus Numerical Rating Scale (PP-NRS) 4-point improvement with both doses compared with placebo.
“We welcome the authorisation by the MHRA of abrocitinib to treat people with moderate to severe atopic dermatitis. This is an important development for people who have moderate to severe disease and need new treatment options,” said Paul Mason, Inflammation and Immunology lead, Pfizer UK.
“Following marketing authorisation, our priority now is to work with NICE to ensure routine access so that those people can benefit from this important treatment,” he added.