AbbVie’s Humira has become the first biologic drug approved in Europe to treat plaque psoriasis in children as young as four.
Humira (adalimumab) – already one of the world’s biggest-selling drugs with sales of $8.5bn last year – can now be used in the EU for children and adolescents with psoriasis who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies, as well as adults.
“Several treatments have been shown to be effective in subgroups of patients with paediatric psoriasis [but] a limited body of supporting data is available,” said Marieke Seyger, a dermatologist at Radboud University Medical Centre in the Netherlands.
“The approval of adalimumab … extends the armamentarium of the physicians who are working to reduce the burden of this chronic disease in this sensitive young patient population,” she added.
The tumour necrosis factor (TNF) blocker is currently licensed in the EU for the treatment of psoriasis, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Humira has been a spectacular product for AbbVie but is facing increased competition in the anti-TNF drug class, with a biosimilar version of one of its main rivals – Janssen and MSD’s Remicade (infliximab) – now on the market in around a dozen countries.
Copies of Humira itself are expected on the market next year when patents on the drug expire in key markets, including the US. Meanwhile, in psoriasis, AbbVie’s drug is expected to face stiff competition from newer biologics including interleukin-17 (IL-17) blockers from Novartis and AstraZeneca/Amgen.
AbbVie is attempting to maintain its lead over the competition by developing a new formulation of Humira that has already been submitted for approval in both the US and EU as well as new delivery devices that – at least for now – remain under wraps.
It is also working on additional indications – hidradenitis suppurativa (HS) and uveitis – that the company believes could add $1bn or more in sales to the franchise.