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AbbVie (ABBV) Provides Clinical Updates on Inflammatory Drugs
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AbbVie (ABBV - Free Report) announced multiple clinical updates pertaining to clinical studies evaluating its blockbuster drugs Skyrizi and Rinvoq for expanded use.
Management announced topline data from the phase III INSPIRE study, which evaluated Skyrizi (risankizumab) as an induction therapy in adult patients with moderately to severely active ulcerative colitis (UC). The study met all its primary and secondary endpoints.
Data from the INSPIRE study showed that treatment with an intravenous 1200mg dose of Skyrizi achieved the primary endpoint of clinical remission at week 12. The data showed that a significantly higher proportion of patients, 20.3% treated with risankizumab achieved the primary endpoint of clinical remission compared to 6.2% of patients on placebo at week 12.
Study participants who were administered Skyrizi also achieved endoscopic and histologic-endoscopic mucosal improvement at week 12, which were also the study’s secondary endpoints. The drug’s safety profile was also consistent with that observed in previous studies in other indications.
In a separate press release, AbbVie also reported positive topline data from a phase II study (SLEek) which evaluated Rinvoq (upadacitinib), alone as well as combined with BTK inhibitor elsubrutinib, in patients with moderately to severely active systemic lupus erythematosus (SLE).
Data from the SLEek study showed that treatment with a 30mg dose of Rinvoq achieved the primary endpoint of the SLE Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24. The drug’s safety profile was also consistent with that observed in previously-conducted studies in other indications. Based on these results, AbbVie is advancing Rinvoq in SLE to phase III development.
Currently, Skyrizi is approved for three indications – plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease. Skyrizi, on the other hand, is approved for rheumatoid arthritis (RA), PsA, UC, ankylosing spondylitis (AS) and eczema indications.
In the year so far, shares of AbbVie have declined 3.9% compared to the industry’s 7.6% fall.
Image Source: Zacks Investment Research
Skyrizi and Rinvoq demonstrated differentiated clinical profiles compared to Humira and are already contributing meaningful revenues, including $7.7 billion in combined sales in 2022. AbbVie is focused on strengthening its focus on new immunology medicines, Skyrizi and Rinvoq, to lessen its dependence on Humira, a major topline driver for AbbVie, which recently lost exclusivity in the United States.
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 (BIIB - Free Report) . Companies like Amgen, Novartis and Biogen were the first to start commercializing a Humira-biosimilar in Europe in 2018.
Earlier this 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. Earlier this week, 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 b0079 2025 and more than $21 billion by 2027.
Image: Shutterstock
AbbVie (ABBV) Provides Clinical Updates on Inflammatory Drugs
AbbVie (ABBV - Free Report) announced multiple clinical updates pertaining to clinical studies evaluating its blockbuster drugs Skyrizi and Rinvoq for expanded use.
Management announced topline data from the phase III INSPIRE study, which evaluated Skyrizi (risankizumab) as an induction therapy in adult patients with moderately to severely active ulcerative colitis (UC). The study met all its primary and secondary endpoints.
Data from the INSPIRE study showed that treatment with an intravenous 1200mg dose of Skyrizi achieved the primary endpoint of clinical remission at week 12. The data showed that a significantly higher proportion of patients, 20.3% treated with risankizumab achieved the primary endpoint of clinical remission compared to 6.2% of patients on placebo at week 12.
Study participants who were administered Skyrizi also achieved endoscopic and histologic-endoscopic mucosal improvement at week 12, which were also the study’s secondary endpoints. The drug’s safety profile was also consistent with that observed in previous studies in other indications.
In a separate press release, AbbVie also reported positive topline data from a phase II study (SLEek) which evaluated Rinvoq (upadacitinib), alone as well as combined with BTK inhibitor elsubrutinib, in patients with moderately to severely active systemic lupus erythematosus (SLE).
Data from the SLEek study showed that treatment with a 30mg dose of Rinvoq achieved the primary endpoint of the SLE Responder Index (SRI-4) and steroid dose less than or equal to 10 mg prednisone equivalent once per day at week 24. The drug’s safety profile was also consistent with that observed in previously-conducted studies in other indications. Based on these results, AbbVie is advancing Rinvoq in SLE to phase III development.
Currently, Skyrizi is approved for three indications – plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease. Skyrizi, on the other hand, is approved for rheumatoid arthritis (RA), PsA, UC, ankylosing spondylitis (AS) and eczema indications.
In the year so far, shares of AbbVie have declined 3.9% compared to the industry’s 7.6% fall.
Image Source: Zacks Investment Research
Skyrizi and Rinvoq demonstrated differentiated clinical profiles compared to Humira and are already contributing meaningful revenues, including $7.7 billion in combined sales in 2022. AbbVie is focused on strengthening its focus on new immunology medicines, Skyrizi and Rinvoq, to lessen its dependence on Humira, a major topline driver for AbbVie, which recently lost exclusivity in the United States.
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 (BIIB - Free Report) . Companies like Amgen, Novartis and Biogen were the first to start commercializing a Humira-biosimilar in Europe in 2018.
Earlier this 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. Earlier this week, 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 b0079 2025 and more than $21 billion by 2027.
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