We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
AbbVie's (ABBV) Skyrizi Meets Ulcerative Colitis Study Goals
Read MoreHide Full Article
AbbVie, Inc. (ABBV - Free Report) announced top-line data from the phase III maintenance study, COMMAND, which evaluated its IL-23 drug Skyrizi (risankizumab) in adult patients with moderately to severely active ulcerative colitis (“UC”) indication.
Data from the COMMAND study showed that a significantly higher proportion of patients treated with Skyrizi (180mg or 360mg, administered subcutaneously) achieved the primary endpoint of clinical remission at week 52.40% and 38% of study participants who received the 180mg and 360mg dose of the drug, respectively, achieved clinical remission, compared to 25% of patients enrolled in the control group.
Study participants who were administered Skyrizi also achieved endoscopic improvement, histologic-endoscopic mucosal improvement and steroid-free remission following 52 weeks of treatment, which were also the study’s key secondary endpoints. The drug’s safety profile was consistent with the data from prior studies in other indications.
Currently, Skyrizi is approved by the FDA for three indications, which are plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (“CD”).
Shares of AbbVie have declined 15.9% so far this year against the industry’s 0.6% rise.
Image Source: Zacks Investment Research
The COMMAND study enrolled only those patients who had responded to induction treatment with the drug in the phase III INSPIRE study. In March, AbbVie reported top-line data from the INSPIRE study, wherein treatment with an intravenous 1200mg dose of Skyrizi achieved the primary endpoint of clinical remission at week 12.
The targeted UC market is highly competitive. AbbVie faces stiff competition from Johnson & Johnson (JNJ - Free Report) , which markets its own drug Stelara which utilizes a similar mechanism of action to treat the CD indication.
A blockbuster drug, J&J’s Stelara is a human IL-12 and IL-23 antagonist approved by the FDA for treating moderately to severely active UC. The drug is also approved for other indications, including psoriasis, CD and PsA. Evidently, Stelara is one of J&J’s top-line drivers. During first-quarter 2023, J&J recorded revenues worth $2.4 billion from Stelara sales.
Last month, the FDA approved AbbVie’s blockbuster JAK inhibitor Rinvoq for the treatment of adults with moderately to severely active CD who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. The approval marks the seventh FDA-approved indication for Rinvoq across rheumatology, dermatology and gastroenterology. Apart from CD, Rinvoq is also approved for rheumatoid arthritis, PsA, UC, ankylosing spondylitis and eczema indications.
AbbVie is focused on strengthening its focus on new immunology medicines, Skyrizi and Rinvoq, to lessen its dependence on Humira, a major top-line driver for AbbVie, which recently lost exclusivity in the United States. Both Skyrizi and Rinvoq demonstrated differentiated clinical profiles, compared to Humira.
Over the years, AbbVie’s Humira sales have been steadily declining due to biosimilars eroding the ex-U.S. sales of the drug. Humira’s international sales are already eroding due to the launch of several direct biosimilar drugs in Europe by other pharma companies, including Amgen (AMGN - Free Report) , Novartis’ (NVS - Free Report) Sandoz division and Biogen. Companies like Amgen, Novartis and Biogen were the first to start commercializing a Humira-biosimilar in Europe in 2018.
In January, Amgen announced the launch of the first Humira biosimilar in the United States. The biosimilar is being marketed by Amgen under the trade name Amjevita. Like Amgen, several other companies like Biogen, Boehringer Ingelheim and Pfizer have also received FDA approvals for their own Humira biosimilars, many of which are expected to be launched at various times this year per agreements with AbbVie. In March 2023, Novartis (through its Sandoz division) announced that the FDA had approved its Humira biosimilar, which will be marketed under the trade name Hyrimoz. The Novartis division intends to market the drug in the United States from July 1, 2023.
With many new indications coming in the next couple of years, AbbVie expects sales of Skyrizi and Rinvoq to be higher and potentially replace Humira. Skyrizi and Rinvoq are expected to collectively exceed the peak revenues achieved by Humira by 2027. Management expects the combined sales (risk-adjusted) of Skyrizi and Rinvoq to be more than $17.5 billion in 2025 and more than $21 billion by 2027.
Image: Shutterstock
AbbVie's (ABBV) Skyrizi Meets Ulcerative Colitis Study Goals
AbbVie, Inc. (ABBV - Free Report) announced top-line data from the phase III maintenance study, COMMAND, which evaluated its IL-23 drug Skyrizi (risankizumab) in adult patients with moderately to severely active ulcerative colitis (“UC”) indication.
Data from the COMMAND study showed that a significantly higher proportion of patients treated with Skyrizi (180mg or 360mg, administered subcutaneously) achieved the primary endpoint of clinical remission at week 52.40% and 38% of study participants who received the 180mg and 360mg dose of the drug, respectively, achieved clinical remission, compared to 25% of patients enrolled in the control group.
Study participants who were administered Skyrizi also achieved endoscopic improvement, histologic-endoscopic mucosal improvement and steroid-free remission following 52 weeks of treatment, which were also the study’s key secondary endpoints. The drug’s safety profile was consistent with the data from prior studies in other indications.
Currently, Skyrizi is approved by the FDA for three indications, which are plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (“CD”).
Shares of AbbVie have declined 15.9% so far this year against the industry’s 0.6% rise.
Image Source: Zacks Investment Research
The COMMAND study enrolled only those patients who had responded to induction treatment with the drug in the phase III INSPIRE study. In March, AbbVie reported top-line data from the INSPIRE study, wherein treatment with an intravenous 1200mg dose of Skyrizi achieved the primary endpoint of clinical remission at week 12.
The targeted UC market is highly competitive. AbbVie faces stiff competition from Johnson & Johnson (JNJ - Free Report) , which markets its own drug Stelara which utilizes a similar mechanism of action to treat the CD indication.
A blockbuster drug, J&J’s Stelara is a human IL-12 and IL-23 antagonist approved by the FDA for treating moderately to severely active UC. The drug is also approved for other indications, including psoriasis, CD and PsA. Evidently, Stelara is one of J&J’s top-line drivers. During first-quarter 2023, J&J recorded revenues worth $2.4 billion from Stelara sales.
Last month, the FDA approved AbbVie’s blockbuster JAK inhibitor Rinvoq for the treatment of adults with moderately to severely active CD who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers. The approval marks the seventh FDA-approved indication for Rinvoq across rheumatology, dermatology and gastroenterology. Apart from CD, Rinvoq is also approved for rheumatoid arthritis, PsA, UC, ankylosing spondylitis and eczema indications.
AbbVie is focused on strengthening its focus on new immunology medicines, Skyrizi and Rinvoq, to lessen its dependence on Humira, a major top-line driver for AbbVie, which recently lost exclusivity in the United States. Both Skyrizi and Rinvoq demonstrated differentiated clinical profiles, compared to Humira.
Over the years, AbbVie’s Humira sales have been steadily declining due to biosimilars eroding the ex-U.S. sales of the drug. Humira’s international sales are already eroding due to the launch of several direct biosimilar drugs in Europe by other pharma companies, including Amgen (AMGN - Free Report) , Novartis’ (NVS - Free Report) Sandoz division and Biogen. Companies like Amgen, Novartis and Biogen were the first to start commercializing a Humira-biosimilar in Europe in 2018.
In January, Amgen announced the launch of the first Humira biosimilar in the United States. The biosimilar is being marketed by Amgen under the trade name Amjevita. Like Amgen, several other companies like Biogen, Boehringer Ingelheim and Pfizer have also received FDA approvals for their own Humira biosimilars, many of which are expected to be launched at various times this year per agreements with AbbVie. In March 2023, Novartis (through its Sandoz division) announced that the FDA had approved its Humira biosimilar, which will be marketed under the trade name Hyrimoz. The Novartis division intends to market the drug in the United States from July 1, 2023.
With many new indications coming in the next couple of years, AbbVie expects sales of Skyrizi and Rinvoq to be higher and potentially replace Humira. Skyrizi and Rinvoq are expected to collectively exceed the peak revenues achieved by Humira by 2027. Management expects the combined sales (risk-adjusted) of Skyrizi and Rinvoq to be more than $17.5 billion in 2025 and more than $21 billion by 2027.
AbbVie Inc. Price
AbbVie Inc. price | AbbVie Inc. Quote
Zacks Rank
AbbVie currently carries a Zacks Rank #3 (Hold).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.