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AbbVie's (ABBV) Rinvoq Gets CHMP Nod for Two New Indications
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AbbVie Inc. (ABBV - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has rendered a positive opinion recommending approval for its promising JAK inhibitor Rinvoq (upadacitinib) to treat two new additional indications.
The company is seeking approval of once daily Rinvoq (15 mg) for the treatment of adult patients with active psoriatic arthritis (PsA) as well as adult patients with active ankylosing spondylitis (“AS”).
The favorable CHMP opinion for the PsA and AS indications was based on data from the three pivotal studies in which treatment with Rinvoq showed efficacy across multiple measures of disease activity.
Importantly, both the SELECT-PsA 1 and SELECT-PsA 2 studies which evaluated Rinvoq for PsA, met the primary endpoint of ACR20 response at week 12 of treatment as compared to placebo. Also, SELECT-AXIS 1 study evaluated Rinvoq for AS, achieved the primary endpoint of Assessment of Spondyloarthritis International Society 40 response at week 14 of treatment versus placebo. Moreover, the safety profile of Rinvoq was similar to data from previous studies and no new safety risk was observed.
Notably, Rinvoq was approved in the EU in December 2019 for treating moderate-to-severe rheumatoid arthritis (“RA”). If approved for the two additional indications, Rinvoq will become the first JAK inhibitor to be approved in Europe for three rheumatologic conditions – RA, PsA and AS.
A final decision from the European Commission for both PsA and AS indications is expected in early 2021.
Shares of AbbVie have rallied 20.1% so far this year compared with the industry’s increase of 4.1%.
Meanwhile, regulatory applications seeking approval for Rinvoq to treat adult patients with AS, PsA as well as moderate-to-severe atopic dermatitis, are also under review in the United States.
Rinvoq generated sales of $450 million in the first nine months of 2020. A further label expansion will significantly boost Rinvoq’s sales in the days ahead.
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. Meanwhile, in the European Union, several biosimilars of Humira have already been launched by the likes of Amgen (AMGN - Free Report) , Biogen (BIIB - Free Report) and Novartis’ (NVS - Free Report) generic subsidiary, Sandoz, which are eroding international sales of Humira.
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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AbbVie's (ABBV) Rinvoq Gets CHMP Nod for Two New Indications
AbbVie Inc. (ABBV - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency has rendered a positive opinion recommending approval for its promising JAK inhibitor Rinvoq (upadacitinib) to treat two new additional indications.
The company is seeking approval of once daily Rinvoq (15 mg) for the treatment of adult patients with active psoriatic arthritis (PsA) as well as adult patients with active ankylosing spondylitis (“AS”).
The favorable CHMP opinion for the PsA and AS indications was based on data from the three pivotal studies in which treatment with Rinvoq showed efficacy across multiple measures of disease activity.
Importantly, both the SELECT-PsA 1 and SELECT-PsA 2 studies which evaluated Rinvoq for PsA, met the primary endpoint of ACR20 response at week 12 of treatment as compared to placebo. Also, SELECT-AXIS 1 study evaluated Rinvoq for AS, achieved the primary endpoint of Assessment of Spondyloarthritis International Society 40 response at week 14 of treatment versus placebo. Moreover, the safety profile of Rinvoq was similar to data from previous studies and no new safety risk was observed.
Notably, Rinvoq was approved in the EU in December 2019 for treating moderate-to-severe rheumatoid arthritis (“RA”). If approved for the two additional indications, Rinvoq will become the first JAK inhibitor to be approved in Europe for three rheumatologic conditions – RA, PsA and AS.
A final decision from the European Commission for both PsA and AS indications is expected in early 2021.
Shares of AbbVie have rallied 20.1% so far this year compared with the industry’s increase of 4.1%.
Meanwhile, regulatory applications seeking approval for Rinvoq to treat adult patients with AS, PsA as well as moderate-to-severe atopic dermatitis, are also under review in the United States.
Rinvoq generated sales of $450 million in the first nine months of 2020. A further label expansion will significantly boost Rinvoq’s sales in the days ahead.
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. Meanwhile, in the European Union, several biosimilars of Humira have already been launched by the likes of Amgen (AMGN - Free Report) , Biogen (BIIB - Free Report) and Novartis’ (NVS - Free Report) generic subsidiary, Sandoz, which are eroding 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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Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
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