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.