Upadacitinib hemihydrate

The therapy was discovered and developed by AbbVie. Credit: © AbbVie Inc. All rights reserved. The European Commission (EC) has granted marketing authorisation for AbbVie’s once-a-day treatment Rinvoq (upadacitinib) 15mg for adults with giant cell arteritis (GCA). It is the first and only oral Janus kinase inhibitor approved in the European Union, Liechtenstein, Norway and Iceland, for this indication. GCA is an autoimmune condition, predominantly affecting individuals over 50, with the highest incidence between 70 and 80 years of age. The condition leads to the inflammation of the aorta, the temporal and cranial arteries, and other large and medium arteries. The authorisation of Rinvoq is based on data from the multicentre Phase III SELECT-GCA trial, which was structured to assess the efficacy and safety of the therapy in 428 GCA subjects. The trial met its primary and key secondary endpoints, demonstrating that 46.4% of subjects treated with 15 mg of the therapy plus a steroid taper regimen for 26 weeks achieved sustained remission at week 52 versus 29% of those on placebo with a steroid taper regimen. AbbVie research and development, chief scientific officer and executive vice-president Roopal Thakkar stated: “The EC approval of Rinvoq in GCA provides patients and physicians with a new treatment option and the first oral advanced therapy for adults living with GCA – a particularly vulnerable population due to older age and frequent comorbidities.” The therapy has previously gained approval in the EU for conditions including psoriatic arthritis, radiographic axial spondylarthritis and Crohn’s disease. Rinvoq has been discovered and developed by company scientists and is currently under investigation for other immune-mediated inflammatory conditions. It is also undergoing Phase III trials for alopecia areata, hidradenitis suppurativa, Takayasu arteritis, vitiligo and systemic lupus erythematosus. In March 2025, the company announced a $2.3bn licensing agreement to acquire global rights to the long-acting amylin analogue, GUB014295, from Danish biotech Gubra.

Novartis has reignited its competitive streak, targeting the reign of Dupixent (dupilumab), the newly crowned “autoimmune drug king” from Sanofi. The company has initiated a head-to-head Phase III trial for its investigational BTK inhibitor remibrutinib against Dupixent, aiming to disrupt the dominance of this top-tier therapeutic. This is not Novartis’ first strike at market leaders. In the past, its blockbuster Cosentyx (secukinumab) outperformed AbbVie's Humira and Johnson & Johnson’s Stelara in direct head-to-head trials, cementing its position as a key player in psoriasis treatment. However, despite these wins, Novartis’ 2024 autoimmune business revenue of $9.293 billion left it short of the $10 billion milestone and outside the top three in the field. Industry giants such as AbbVie, Johnson & Johnson, and Sanofi dominate the autoimmune space with super blockbuster drugs. AbbVie leads with a commanding $11.7 billion in Skyrizi sales and strong growth from Rinvoq, while Johnson & Johnson relies on products like Stelara and Tremfya. Sanofi, with Dupixent achieving $14.2 billion in sales, has solidified its position as the third-largest player in the sector. Novartis, though just shy of the $10 billion mark, is not backing down. Cosentyx, its flagship IL-17A inhibitor, has driven significant revenue growth, reaching $6.141 billion in 2024 sales, thanks to approvals for multiple indications like plaque psoriasis and psoriatic arthritis. Expansion into conditions such as polymyalgia rheumatica (PMR) and giant cell arteritis (GCA), with Phase III trial results expected in 2025, could further elevate its market potential to $8 billion in peak sales. Yet, its other autoimmune drugs lag behind. Xolair (omalizumab), co-developed with Roche, generated $1.643 billion outside the US, but faces increasing pressure from Dupixent, which is now approved for chronic spontaneous urticaria (CSU) in Japan and awaiting FDA approval. Additionally, Chinese competitors are advancing innovative IgE-targeting therapies, challenging Xolair’s dominance. To counter these threats, Novartis has taken bold steps. It became the first company to file for remibrutinib’s approval in CSU treatment in China and has begun the RECLAIM Phase III trial, comparing remibrutinib directly with Dupixent. As a highly selective, oral, and irreversible BTK inhibitor, remibrutinib offers convenience over injectable biologics, with Novartis projecting $3 billion in peak sales. Additionally, Novartis secured an $830 million deal with Kyorin Pharmaceutical to develop MRGPRX2 antagonists like KRP-M223, targeting allergic and inflammatory mast cell diseases such as CSU. This emerging class of drugs represents a blue ocean market, with few competitors currently in clinical trials. Novartis is also advancing a robust autoimmune pipeline, with 15 early-stage and 8 late-stage clinical programs exploring diverse mechanisms, including NLRP3 inhibitors, CD19 CAR-T therapies, and BAFF-R monoclonal antibodies. Analysts suggest that Novartis’ strategy of head-to-head trials, pipeline diversification, and strategic licensing could help secure its place in the $100 billion autoimmune market. While challenges remain, including strong competition from Sanofi and Johnson & Johnson, Novartis’ aggressive moves could reshape the landscape, positioning it as a leading force in the autoimmune sector.