AbbVie Inc. ABBV announced that it has submitted regulatory applications both to the FDA and the European Medicines Agency (EMA) for expanding the label of its JAK inhibitor Rinvoq (upadacitinib). The company is seeking approval of once daily Rinvoq (15 mg) for the treatment of adult patients with active psoriatic arthritis.
Rinvoq was approved by the FDA in August and by EMA in December last year for treating for moderate-to-severe rheumatoid arthritis (RA).
The regulatory filings for active psoriatic arthritis were based on data from two phase III studies, which evaluated Rinvoq in more than 2,000 patients. Rinvoq met the primary endpoint of ACR20 response at week 12 versus placebo in both studies. The drug demonstrated improved joint outcomes, physical function and skin symptoms with a greater proportion of patients achieving minimal disease activity versus placebo.
Moreover, Rinvoq achieved non-inferiority versus AbbVie’s blockbuster drug Humira (adalimumab) in terms of ACR20 response at week 12.
Shares of AbbVie have increased 2.4% so far this year against the industry’s decrease of 1.7%.
Notably, the early uptake trends of Rinvoq have been encouraging so far. The drug generated sales of $86 million in the first quarter of 2020 compared with $33 million recorded in the fourth quarter of 2019. AbbVie expects Rinvoq global revenues to be approximately $500 million for 2020.
Apart from psoriatic arthritis, Rinvoq is being evaluated in several studies for other indications. The drug is also being studied for Crohn’s disease, ulcerative colitis, axial spondyloarthritis, atopic dermatitis and giant cell arteritis. A further label expansion will significantly boost Rinvoq’s sales in the days ahead.
We note that the nod to Rinvoq and another drug Skyrizi (risankizumab) may bode well for AbbVie in the long haul and could offset the potential decline in Humira’s sales following the launch of biosimilars in the United States, which is scheduled for 2023. In the EU, several biosimilars of Humira are already unveiled by companies including Amgen AMGN, Biogen BIIB and Novartis’ NVS generic subsidiary Sandoz, which significantly lowered the international sales of Humira.
AbbVie currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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