The Medicines and Healthcare Products Regulatory Agency (MHRA) has approved Abbvie’s oral JAK inhibitor Rinvoq (upadacitinib) for the treatment of moderate to severe atopic dermatitis – the most common form of eczema – in adults and adolescents 12 years and older who are candidates for systemic therapy.
The MHRA approval follows the drug’s recent European Commission (EC) approval, and is supported by data from one of the largest registrational Phase III programmes in atopic dermatitis, evaluating Rinvoq monotherapy or with topical corticosteroids.
Rinvoq met all primary and secondary endpoints in this study, demonstrating rapid and significant improvement in skin clearance and itch reduction compared to placebo at week 16 and earlier time points. Results at week 16 continued to be maintained through week 52, AbbVie added in a statement.
“As a dermatologist, researching and treating atopic dermatitis, I see first-hand the debilitating impact this disease can have on a person's daily life,” said Dr Andrew Pink, Rinvoq clinical study investigator and consultant dermatologist at St John’s Institute of Dermatology, Guy’s and St Thomas’ NHS Foundation Trust.
“We need more systemic treatments to treat this debilitating disease and it is therefore really encouraging to see the positive and rapid effect of upadacitinib in trials," he added.
Andrew Proctor, chief executive of the National Eczema Society commented: “Atopic dermatitis can impact and profoundly affect a person’s physical and mental health, their quality of life and even their life chances. The MHRA approval of upadacitinib is welcome news for the many people living with atopic dermatitis who need there to be a wide range of treatment options to help them manage this life-long, heterogenous inflammatory skin disease.”
Rinvoq is now MHRA-approved across four indications including atopic dermatitis, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis.