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AbbVie (ABBV) Files for Skyrizi to Treat Crohn's Disease in EU

AbbVie (ABBV) submits a regulatory application in the European Union, seeking approval for risankizumab (Skyrizi) for the treatment of Crohn's disease.

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This story originally appeared on Zacks

AbbVie, Inc. ABBV announced that it submitted a regulatory application with the European Medicines Agency (EMA), seeking approval for its interleukin-23 (“IL-23”) inhibitor risankizumab (Skyrizi) as a potential treatment of moderate-to-severe Crohn’s disease (CD).

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The regulatory filing seeks approval for Skyrizi, both as a 600mg intravenous (IV) induction and a 360mg subcutaneous (SC) maintenance therapy in patients aged 16 years and older with CD, who have had inadequate response, lost response or were intolerant to conventional or biologic therapy.

The filing is supported by data from the three phase III studies, namely ADVANCE, MOTIVATE and FORTIFY, which evaluated the safety and efficacy of Skyrizi in CD patients. In all three studies, participants administered with Skyrizi achieved the co-primary endpoints of clinical remission and endoscopic response compared to placebo.

In the year so far, AbbVie’s stock price has increased 7.6% compared with the industry’s 11.8% rise.

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Please note that Skyrizi is already approved in the EU for two indications - plaque psoriasis and active psoriatic arthritis.

The drug is also approved in the United States for the plaque psoriasis indication. Two supplemental new drug applications seeking approval for Skyrizi to treat active psoriatic arthritis and CD are currently under review by the FDA.

Apart from the above indications, AbbVie is currently evaluating Skyrizi in a phase III study for ulcerative colitis.

AbbVie is developing Skyrizi in collaboration with Boehringer Ingelheim, with AbbVie leading the global development and commercialization of Skyrizi.

AbbVie remains focused on strengthening its focus on Skyrizi and its other drug Rinvoq to gradually lower its dependence on Humira, the company’s blockbuster drug, sales of which are declining due to biosimilars that are eroding AbbVie’s yearly international sales. Humira biosimilars are expected to be launched in the United States in 2023.

Both Skyrizi and Rinvoq demonstrated differentiated clinical profiles compared to Humira. With many new indications coming in the next couple of years, AbbVie expects sales of these two drugs to be higher with the potential to replace Humira.

Skyrizi generated sales worth $2.04 billion in the first nine months of 2021, while Rinvoq generated sales worth $1.33 during the same period.

Zacks Rank & Stocks to Consider

AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector are Endo International ENDP, GlaxoSmithKline GSK and IVERIC bio ISEE. While Endo International sports a Zacks Rank #1 (Strong Buy), both GlaxoSmithKline and IVERIC bio carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Endo International’s earnings per share estimates for 2021 have increased from $2.32 to $2.84 in the past 30 days. The same for 2022 has increased from $2.25 to $2.47 in the past 30 days.

Earnings of Endo International beat estimates in all the last four quarters, the average being 57.7%.

GlaxoSmithKline’s earnings estimates per share for 2021 have increased from $2.90 to $3.06 in the past 30 days. The same for 2022 has increased from $3.15 to $3.26 in the past 30 days. Shares of Glaxo have risen 11.7% in the year so far.

Earnings of GlaxoSmithKline beat estimates in three of the last four quarters and missed expectations on one occasion, the average surprise being 15.3%.

IVERIC bio’s loss per share estimates for 2021 have narrowed from $1.18 to $1.12 in the past 30 days. The same for 2022 has narrowed from $1.17 to $1.10 in the past 30 days. Shares of IVERIC bio have gained 111.6% in the year so far.

Earnings of IVERIC bio missed estimates in three of the last four quarters and surpassed expectations once, the negative surprise being 5.6%, on average.



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