AbbVie’s Humira receives first European OK for skin condition
pharmafile | August 3, 2015 | News story | Sales and Marketing | AbbVie, Hidradenitis suppurativa, Humira, adalimumab
The European Commission has approved AbbVie’s Humira as a treatment for moderate-to-severe hidradenitis suppurativa – a chronic condition affecting the skin.
The approval of Humira (adalimumab) is the first time an approved therapy has become available for this condition, for adults who do not respond to conventional treatment.
Hidradenitis suppurativa (HS) is a painful, chronic, systemic inflammatory disorder. It causes inflamed nodules, boils and abscesses around the armpits and groin, which often release pus. Patients with moderate and severe forms of the condition have recurrent abscesses, which leads to scarring and other skin problems. AbbVie says the approval means that for the first time HS patients will be able to use a systemic treatment that tackles an underlying cause of the disease.
“This new indication for Humira demonstrates AbbVie’s continuing commitment to innovate with this leading therapy, by seeking to address unmet clinical need and provide new solutions for difficult-to-treat diseases, says AbbVie UK’s medical director, Dr Neil Pumford. “Trials show the very positive impact that adalimumab can have on patients living with HS including the most severe forms of the disease.
“Before the launch of adalimumab the only option HS patients had was to use unproven therapies with limited efficacy and surgical procedures, none of which treated the underlying causes of the disease. Now they have the option of an established biologic treatment with robust clinical evidence. This gives real hope to people with HS”.
Dr David Fitzgerald, consultant dermatologist at the Salford Royal NHS Foundation Trust, says: “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.
He adds: “For the first time clinicians treating HS have, in Humira, a licensed and proven therapy. The PIONEER results are particularly positive as Humira not only significantly reduces patients’ flares but also significantly reduces the associated pain, one of the most difficult aspects of living with the disease. The launch of the first licensed therapy for HS should help us to improve the management of the disease and to enable us to achieve better outcomes in this under-recognised but debilitating condition.”
Adalimumab’s approval follows Phase III studies which found that it significantly improved disease activity and pain in patients with moderate to severe HS. The drug was given a positive opinion by the European Medicines Agency in June. In May, the FDA granted Humira orphan drug designation for the same indication, moderate-to-severe hidradenitis suppurativa.
Yasmita Kumar
Related Content
Genmab to submit FDA application for lymphoma therapy
Global biotechnology company Genmab plans to submit a supplemental Biologics License Application (sBLA) to the …
The National Institute for Health and Care Excellence announce technology appraisal guidance recommending risankizumab for adult patients with moderate to severe ulcerative colitis
The National Institute for Health and Care Excellence (NICE) have recommended adult patients in England …
Abbvie acquires Cerevel Therapeutics
Abbvie has announced the acquisition of Cerevel Therapeutics, strengthening its neuroscience pipeline. Cerevel has multiple …
