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AbbVie's (ABBV) Skyrizi Crohn's Disease Study Meets Goals
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AbbVie (ABBV - Free Report) announced that its key drug, Skyrizi (risankizumab) met all primary and secondary endpoints of a head-to-head phase III study comparing the drug against J&J’s (JNJ - Free Report) blockbuster medicine, Stelara (ustekinumab) in Crohn’s disease.
The phase III study called SEQUENCE compared Skyrizi to J&J’s Stelara for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNF therapies.
The first primary endpoint was non-inferiority for clinical remission (Crohn's Disease Activity Index [CDAI]) at week 24. The remission rates were 59% in the Skyrizi arm and 40% in the Stelara arm, thereby showing the non-inferiority of Skyrizi versus Stelara.
The second primary endpoint was the superiority of endoscopic remission at week 48. The remission rates were 32% in the Skyrizi arm and 16% in the Stelara arm, demonstrating superiority.
Statistical significance was also achieved for all of the study’s secondary endpoints for superiority of Skyrizi over Stelara.
Skyrizi, an interleukin-23 (IL-23) inhibitor, is presently approved in several countries, including the United States and Europe, for treating moderate-to-severe Crohn's disease, active psoriatic arthritis and moderate-to-severe psoriasis. While Skyrizi is already approved for Crohn's disease, the data from the head-to-head study shows that Skyrizi can also be an effective medicine to treat the disease and help eligible patients achieve clinical and endoscopic treatment goals.
Year to date, AbbVie’s shares have lost 7.6% against the industry’s 9.1% rise.
Image Source: Zacks Investment Research
Skyrizi recorded sales of $2.77 billion in the first half of 2023, up 49% year over year on an operational basis. Skyrizi and AbbVie’s other newer inflammatory drug, Rinvoq are performing extremely well, bolstered by approvals in new indications. Both have the potential to drive the top line to make up for lost Humira revenues.
AbbVie’s key blockbuster immunology medicine, Humira lost patent protection in the United States in 2023.InJanuary, Amgen (AMGN - Free Report) launched the first Humira biosimilar in the United States called Amjevita. After Amgen, several other companies like Boehringer Ingelheim, Coherus BioSciences and Novartis (NVS - Free Report) also launched their own Humira biosimilars. Novartis, through its generic division, Sandoz, markets its Humira biosimilar under the trade name Hyrimoz. Humira biosimilars were launched in the EU in October 2018. These biosimilars have been eroding international sales from the branded drug since 2019.
Skyrizi and Rinvoq recorded $4.85 billion in AbbVie’s combined sales in the first half of 2023.
AbbVie launched Skyrizi and Rinvoq across Humira's major indications, plus a distinct new indication, atopic dermatitis. With approvals for many new indications, sales of these drugs could be higher in future quarters, thus supporting top-line growth. Skyrizi and Rinvoq are expected to collectively exceed the peak revenues achieved by Humira by 2027. AbbVie expects combined sales (risk-adjusted) of Skyrizi and Rinvoq to be more than $17.5 billion by 2025 and more than $21 billion by 2027.
AbbVie is developing Skyrizi in collaboration with Boehringer Ingelheim, with AbbVie leading the global development and commercialization of Skyrizi.
Image: Bigstock
AbbVie's (ABBV) Skyrizi Crohn's Disease Study Meets Goals
AbbVie (ABBV - Free Report) announced that its key drug, Skyrizi (risankizumab) met all primary and secondary endpoints of a head-to-head phase III study comparing the drug against J&J’s (JNJ - Free Report) blockbuster medicine, Stelara (ustekinumab) in Crohn’s disease.
The phase III study called SEQUENCE compared Skyrizi to J&J’s Stelara for the treatment of adult patients with moderately to severely active Crohn's disease who have failed one or more anti-TNF therapies.
The first primary endpoint was non-inferiority for clinical remission (Crohn's Disease Activity Index [CDAI]) at week 24. The remission rates were 59% in the Skyrizi arm and 40% in the Stelara arm, thereby showing the non-inferiority of Skyrizi versus Stelara.
The second primary endpoint was the superiority of endoscopic remission at week 48. The remission rates were 32% in the Skyrizi arm and 16% in the Stelara arm, demonstrating superiority.
Statistical significance was also achieved for all of the study’s secondary endpoints for superiority of Skyrizi over Stelara.
Skyrizi, an interleukin-23 (IL-23) inhibitor, is presently approved in several countries, including the United States and Europe, for treating moderate-to-severe Crohn's disease, active psoriatic arthritis and moderate-to-severe psoriasis. While Skyrizi is already approved for Crohn's disease, the data from the head-to-head study shows that Skyrizi can also be an effective medicine to treat the disease and help eligible patients achieve clinical and endoscopic treatment goals.
Year to date, AbbVie’s shares have lost 7.6% against the industry’s 9.1% rise.
Image Source: Zacks Investment Research
Skyrizi recorded sales of $2.77 billion in the first half of 2023, up 49% year over year on an operational basis. Skyrizi and AbbVie’s other newer inflammatory drug, Rinvoq are performing extremely well, bolstered by approvals in new indications. Both have the potential to drive the top line to make up for lost Humira revenues.
AbbVie’s key blockbuster immunology medicine, Humira lost patent protection in the United States in 2023.InJanuary, Amgen (AMGN - Free Report) launched the first Humira biosimilar in the United States called Amjevita. After Amgen, several other companies like Boehringer Ingelheim, Coherus BioSciences and Novartis (NVS - Free Report) also launched their own Humira biosimilars. Novartis, through its generic division, Sandoz, markets its Humira biosimilar under the trade name Hyrimoz. Humira biosimilars were launched in the EU in October 2018. These biosimilars have been eroding international sales from the branded drug since 2019.
Skyrizi and Rinvoq recorded $4.85 billion in AbbVie’s combined sales in the first half of 2023.
AbbVie launched Skyrizi and Rinvoq across Humira's major indications, plus a distinct new indication, atopic dermatitis. With approvals for many new indications, sales of these drugs could be higher in future quarters, thus supporting top-line growth. Skyrizi and Rinvoq are expected to collectively exceed the peak revenues achieved by Humira by 2027. AbbVie expects combined sales (risk-adjusted) of Skyrizi and Rinvoq to be more than $17.5 billion by 2025 and more than $21 billion by 2027.
AbbVie is developing Skyrizi in collaboration with Boehringer Ingelheim, with AbbVie leading the global development and commercialization of Skyrizi.
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.
AbbVie Inc. Price and Consensus
AbbVie Inc. price-consensus-chart | AbbVie Inc. Quote