AbbVie Inc. ABBV announced that it has submitted a regulatory application to the FDA for expanding the label of its promising JAK inhibitor Rinvoq (upadacitinib). The company is seeking approval for once daily Rinvoq (15 mg) to treat adult patients with active ankylosing spondylitis.
Rinvoq was approved last year for addressing moderate-to-severe rheumatoid arthritis.
We also note that earlier this year, AbbVie filed a marketing application to the EMA for Rinvoq to treat the condition of active ankylosing spondylitis.
The regulatory filing for active ankylosing spondylitis was based on data from the phase II/III study SELECT-AXIS 1. More than 50% patients receiving Rinvoq met the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response at week 14 compared to placebo. Treatment with Rinvoq significantly improved the signs and symptoms in patients with active ankylosing spondylitis.
Per the company, the safety profile of Rinvoq for ankylosing spondylitis was similar to the previously reported studies related to rheumatoid arthritis, atopic dermatitis and psoriatic arthritis with no new significant safety risks observed.
Shares of AbbVie have increased 6.2% so far this year compared with the industry’s rise of 2%.
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Notably, the early uptake trends of Rinvoq have been encouraging so far. The drug generated sales of $235 million in the first six months of 2020. AbbVie expects Rinvoq’s global revenues to be approximately $600 million for the current year.
Apart from ankylosing spondylitis, Rinvoq is being evaluated in several studies for other indications. The drug is also being studied for Crohn’s disease, ulcerative colitis, psoriatic arthritis, axial spondyloarthritis, atopic dermatitis and giant cell arteritis. A further label expansion will significantly boost Rinvoq’s sales in the days ahead.
Moreover, AbbVie recently announced successful data from four late-stage studies on Rinvoq for atopic dermatitis. In June 2020, the company also submitted regulatory applications both to the FDA and the EMA for the medicine to treat adult patients with active psoriatic arthritis.
We note that the approval for Rinvoq and another immunology 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 its biosimilars in the United States, which is scheduled for 2023. In the EU, several biosimilars of Humira are already unveiled by companies like Amgen AMGN, Biogen BIIB and Novartis’ NVS generic subsidiary Sandoz, which in turn, significantly lowered the international sales of Humira.
Zacks Rank
AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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