AbbVie’s JAK inhibitor upadacitinib gets Priority Review

AbbVie’s attempts to diversify beyond Humira have been boosted as its investigational drug upadacitinib has been granted Priority Review by the FDA for moderate to severe rheumatoid arthritis (RA).

Trial data has suggested that upadacitinib, a JAK1-selective inhibitor, is more effective at treating RA than Humira. Some analysts predict sales could eventually reach $3 billion a year or more.

The drug is also being studied in other immune-mediated diseases – phase 3 trials of upadacitinib in atopic dermatitis, psoriatic arthritis, Crohn's disease, and ulcerative colitis are ongoing and it is also being investigated to treat ankylosing spondylitis.

AbbVie’s RA treatment Humira is the biggest selling drug in the world, but may not hold that position for much longer in the face of growing biosimilar competition.

Last month AbbVie announced that its fourth-quarter revenues had missed forecasts; although revenues from Humira grew 1% to $4.9 billion in the quarter year-on-year they were down from more than $5.1 billion in the prior three-month period.

US sales of Humira (adalimumab), where the drug will likely still have patent protection till 2023, were actually up around 9%, but international sales fell almost 15% – or a little under $300 million – due to direct biosimilar competition in Europe and other international markets.

The company is expecting the biosimilar hit on Humira’s international sales for the full year to be around $2 billion.

Upadacitinib is not the company’s only attempt at diversifying its portfolio. Interleukin-23 inhibitor risankizumab for plaque psoriasis is being tipped as a potential $2.5 billion product after beating Johnson & Johnson’s rival IL-23 drug Tremfya (guselkumab) in a head-to-head trial. And the company is also looking to grow established products in other therapeutic categories, such as Imbruvica (ibrutinib) and Venclexta (venetoclax) for blood cancers.

Upadacitinib will face two main JAK inhibitor competitors – Eli Lilly’s Olumiant and Pfizer’s Xeljanz. Despite excitement surrounding the class, though, these treatments all face a complex, competitive market – especially with a number of low-cost biosimilars of injectable biologics on their way.

But the advantages of convenient oral administration with JAK inhibitors may override cost considerations that would otherwise favour biosimilar uptake.

AbbVie said it anticipates a regulatory decision on upadacitinib from the FDA in Q3 2019. The drug is also under review by the European Medicines Agency for the treatment of adult patients with moderate to severe rheumatoid arthritis.