The good news about Humira just keeps coming as Abbott Laboratories announced that European regulators have given the green light for the drug to be used as a treatment for moderate to severe psoriasis.
The approval means that psoriasis is the fifth disease indication granted to Humira (adalimumab) in Europe, as the tumour necrosis factor blocker is already approved for the treatment of rheumatoid and psoriatic arthritis, as well as ankylosing spondylitis and Crohn’s disease.
In one of the two clinical trials submitted to support the marketing application, more than 80% of patients taking Humira achieved skin clearance of 75% or better and in another, almost three-quarters of them achieved that same level of clearance. In both studies, nearly half of the patients on Abbott’s drug enjoyed 90% clearance as early as 16 weeks into treatment.
Abbott noted the comments of Jean-Hilaire Saurat, chairman of the department of dermatology at the University of Geneva, who noted that psoriasis “is not only a skin disease – it is a systemic, autoimmune disorder that, in its more severe forms, may require systemic treatment”. He added that Humira is “the first and only biologic that has been compared to methotrexate, and this approval brings an important new option for dermatologists”.
Noting that patients taking Humira not only experienced rapid, significant skin clearance but also maintained improvement for up to a year, Eugene Sun, vice president of global pharmaceutical clinical development at Abbott, said this fifth approval “demonstrates its versatility in effectively treating multiple autoimmune disorders”. The company noted that a regulatory application for Humira to treat psoriasis is also under review with the US Food and Drug Administration.
Humira sales in the third quarter leapt 48.5% in the third quarter to $803 million and this figure can only rise with the new approval.
