Novartis' Cosentyx misses main goal in head-to-head trial with AbbVie's Humira
After reporting positive data in non-radiographic axial spondyloarthritis last month, Novartis’ blockbuster Cosentyx was dealt a setback on Friday.
In the 52-week EXCEED trial in 800 biologic-naïve active psoriatic arthritis patients, the IL-17A drug was tested against AbbVie’s flagship Humira. The main goal of the study was to show Cosentyx was statistically superior using response rates to ACR20, a standard measure that looks for a 20% recovery in the number of tender and number of swollen joints, and a 20% improvement in three other categories at week 52.
Although Cosentyx monotherapy resulted in higher results versus Humira, it “narrowly” missed the main goal of statistical superiority. Detailed data will be presented at a later date.
Cosentyx — approved for psoriatic arthritis, plaque psoriasis and ankylosing spondylitis — has been Novartis’ biggest seller in the first nine months of 2019, generating about $2.6 billion in sales over the period. It inhibits a protein called IL-17A from binding to its receptor and was the first-ever approved such therapy to secure approval, launching in 2015.
Since then, rivals have emerged, including Eli Lilly’s IL-17A therapy Taltz, and J&J’s anti-IL23 Tremfya. Bausch Health’s (formerly Valeant’s) Siliq targets IL-17RA and is approved for plaque psoriasis, but is currently being evaluated for psoriatic arthritis.
For AbbVie, its TNF inhibitor Humira — approved for an array of autoimmune conditions — has been the gift that keeps giving. The drug — which hit a stupendous $20 billion in sales last year, earning it the crown of the world’s best selling therapy — has begun to see erosion in European sales due to biosimilar competition, and a US patent cliff is looming.
In August, AbbVie’s JAK inhibitor upadacitinib secured FDA approval as part of the drugmaker’s post-Humira plans. But the class of drugs has been blighted by safety concerns — consequently, upadacitinib’s approval was accompanied by a black box warning. Meanwhile, AbbVie has also planned for a post-Humira world with a $63 billion deal to swallow Allergan and its keystone Botox franchise.