AbbVie Inc. ABBV announced that the phase III induction study – U-ACHIEVE, which evaluated its promising JAK inhibitor Rinvoq (upadacitinib), for treating adult patients with moderate to severe ulcerative colitis, has met the primary endpoint.
The U-ACHIEVE study is the first of two phase III induction studies which are investigating the safety and efficacy of once daily Rinvoq (45 mg) for the given indication. Data from the study showed that 26% of patients who were treated with Rinvoq achieved clinical remission – the primary endpoint as compared to only 5% patients who received placebo.
Moreover, the study also met all ranked secondary endpoints, including clinical, endoscopic and histologic outcomes. 36% of patients who were treated with Rinvoq achieved endoscopic improvement compared to only 7% patients who received placebo at week 8 of treatment. Also, 30% of patients who received Rinvoq achieved histologic-endoscopic mucosal improvement versus 7% of patients in the placebo arm at week 8 of treatment.
Importantly, the safety profile of Rinvoq was similar to data from previous studies and no new safety risks were observed.
Shares of AbbVie have rallied 22.7% so far this year compared with the industry’s increase of 4%.
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Rinvoq was approved in 2019 for treating moderate-to-severe rheumatoid arthritis (RA).
Apart from ulcerative colitis, Rinvoq is being evaluated in several studies for endoscopic improvement.
Meanwhile, regulatory applications seeking approval for Rinvoq to treat adult patients with active ankylosing spondylitis, active psoriatic arthritis as well as moderate-to-severe atopic dermatitis, are already under review in the United States and Europe.
Rinvoq generated sales of $450 million in the first nine months of 2020. AbbVie expects Rinvoq’s global revenues to be approximately $700 million for the current year. A further label expansion will significantly boost Rinvoq’s sales in the days ahead.
We note that Rinvoq, along with AbbVie’s another immunology drug, Skyrizi (risankizumab), might be the catalyst for AbbVie’s growth in the long run and could offset the potential decline in Humira’s sales following the launch of its biosimilars in the United States, scheduled for 2023. In the European Union, several biosimilars of Humira have already been launched by the likes of Amgen AMGN, Biogen BIIB and Novartis’ NVS generic subsidiary, Sandoz, which is eroding the international sales of Humira.
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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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