雅虎香港財經 AbbVie's (ABBV) Skyrizi Gets FDA Nod for Ulcerative Colitis
AbbVie ABBV announced that the FDA has granted approval to its blockbuster drug, Skyrizi to treat adults with moderately to severely active ulcerative colitis (UC) in the United States.
Skyrizi’s approval for the UC indication was based on data from two phase III studies, a 12-week induction study, INSPIRE1 and a 52-week maintenance study, COMMAND2. Both studies achieved the primary endpoint of clinical remission. The studies also achieved a key secondary endpoint of endoscopic improvement.
Skyrizi is already approved in the United States and the EU for treating three other immune-mediated inflammatory diseases — plaque psoriasis, psoriatic arthritis and Crohn's disease (“CD”). AbbVie has also submitted an application in the EU, seeking approval for Skyrizi for the UC indication.
Year to date, AbbVie’s stock has risen 10.6% compared with a rise of 19.9% for the industry.
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Skyrizi is a key top-line driver for AbbVie. The drug generated sales of $2.01 billion in the first quarter of 2024, up 48% year over year on an operational basis, reflecting strong volume growth and continued market share gains. AbbVie has a collaboration with Boehringer Ingelheim for Skyrizi with AbbVie leading development and commercialization globally.
Skyrizi and AbbVie’s another inflammatory disease drug Rinvoq are performing extremely well, bolstered by approvals in new indications. The drugs have the potential to replace revenues lost from blockbuster drug Humira, which started facing generic erosion in the United States in early 2023. 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 $27 billion by 2027
UC is a form of inflammatory bowel disease (“IBD”). Skyrizi’s approval for the UC indication has strengthened AbbVie’s portfolio across IBD. IBD also includes another condition, CD.
Skyrizi is the first IL-23 antagonist approved for the UC and CD indications. On the first-quarter conference call, the company said that in IBD, Skyrizi has been seeing tremendous uptake in CD. The company expects rapid patient access for the UC indication for which approval has now been received. AbbVie expects the IBD indication to add more than $1 billion of incremental sales growth for Skyrizi in 2024. Like Skyrizi, Rinvoq is also approved for IBD indications, CD and UC.
Both CD and UC are characterized by chronic inflammation in the gastrointestinal tract. In recent years, there has been a surge in CD and UC cases due to genetic factors, environmental factors and lifestyle changes. In addition, immune system irregularities, higher diagnosis rates, increased focus on early diagnosis and favorable reimbursement policies in developed countries are driving demand for IBD treatments.
Several big drugmakers are developing new medicines to treat UC and CD with novel mechanisms of action to help patients achieve long-term clinical remission. Large drugmakers are acquiring smaller biotechs, making IBD candidates with improved clinical profiles.
For example, in May, AbbVie closed its previously announced acquisition of Landos Biopharma, which added Landos’ lead pipeline candidate, NX-13, which is a first-in-class, oral NLRX1 agonist in phase II development for the treatment of UC. Earlier this month, AbbVie in-licensed exclusive global rights to develop and commercialize FG-M701, a next-generation TL1A antibody for the treatment of IBD indications from the Chinese biotech FutureGen Biopharmaceutical.
In June 2023, Merck MRK acquired the small biotech Prometheus Biosciences, which added tulisokibart/MK-7240 to its pipeline. Merck is developing MK-7240, a novel TL1A inhibitor, for the treatment of UC, CD and other autoimmune conditions.
In October 2023, Sanofi SNY in-licensed rights to jointly develop and commercialize Teva Pharmaceutical’s TEVA IBD candidate, TEV’574, also an anti-TL1A therapy. Teva has partnered with Sanofi for its anti-TL1A candidate to maximize the value of the asset. TEV’574 is presently being evaluated in a phase IIb study for UC and CD.
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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