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Humira gains EU licence first for Hidradenitis Suppurativa

Thirteenth licence for the drug in Europe

Humira packshotAbbVie's blockbuster autoinflammatory drug Humira (adalimumab) has picked up its thirteenth indication as the European Commission approves its use in a chronic skin disorder.

Specifically, Humira can now be used in patients with moderate to severe Hidradenitis Suppurativa (HS) - and marks the first therapy ever to be approved for the disease. 

HS is a painful, chronic, systemic inflammatory disorder, characterised by inflamed nodules, boils and abscesses, typically located around the armpits and groin, which often release unpleasant-smelling pus.

Patients with moderate and severe forms of the condition have recurrent abscesses, which leads to scarring and the development of sinus tracts. The disease is not rare but has until this week no approved medicine for the condition - AbbVie says it affects around one million people in the UK alone.

Dr David Fitzgerald, consultant dermatologist at Salford Royal NHS Foundation Trust, said: “The approval of Humira to treat moderate to severe HS is a major step forward in supporting patients with this distressing and life-changing condition. Patients with HS can experience immense pain and the condition often dramatically impacts their psychological wellbeing and quality of life.”

This builds on an already large number of licences for Humira, which is also indicated for a many autoinflammatory disorders, including: rheumatoid arthritis, psoriasis and psoriatic arthritis.

The drug was the biggest-selling in the world last year, bringing in around $11bn for the firm. It is however under threat from cheaper biosimilar copycats, which could begin to flood the market towards the end of the decade.

New licences - and therefore longer patent lives - will help keep Humira's sales up, but it will likely lose its biggest-seller crown by the end of the year.

This is because sales from Gilead's new combination hep C pill Harvoni (ledipasvir and sofosbuvir) grew to an astonishing $7.2bn in the first six months of 2015, putting it on track to be top of the sales leader board.

Article by
Ben Adams

31st July 2015

From: Regulatory



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