AbbVie (ABBV) Files for Skyrizi in Crohn's Disease With FDA

·3 min read

AbbVie, Inc. ABBV announced that it has submitted a regulatory application in the United States, seeking approval for its interleukin-23 (“IL-23”) inhibitor Skyrizi (risankizumab) as a potential treatment for moderate to severe Crohn’s disease (“CD”).

The regulatory filing seeks approval for Skyrizi both as a 600mg intravenous (“IV”) induction and 360mg subcutaneous (“SC”) maintenance therapy in patients aged 16 years and older with CD.

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

In the year so far, Abbvie’s stock price has declined 0.7% against the industry’s 8.5% rise.

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Both the ADVANCE and MOTIVATE studies evaluated Skyrizi IV induction therapy in CD patients across a 12-week treatment period at two different doses - 600mg or 1200mg. Conversely, the FORTIFY study — a maintenance study — evaluated Skyrizi SC in patients who responded to treatment in the ADVANCE and MOTIVATE studies across a 52-week period at two different doses - 360mg or 180mg.

Data from all the three studies also demonstrated that the safety profile of Skyrizi in CD patients was consistent with the general safety profile of Skyrizi. The drug is already approved in both the United States and European Union to treat adults with moderate to severe plaque psoriasis who are also candidates for systemic therapy or phototherapy.

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

Last week, the company also announced that it has submitted regulatory applications to both the FDA and EMA seeking approval for another new drug, Rinvoq, to treat adult patients with moderate to severe active ulcerative colitis. Rinvoq is already approved in the United States and Europe for rheumatoid arthritis.

Both Skyrizi and Rinvoq have demonstrated differentiated clinical profiles in comparison to AbbVie’s blockbuster drug Humira, whose biosimilars are eroding the company’s yearly international sales. With many new indications coming in the next couple of years, sales of these drugs could be higher and gradually lower the company’s dependence on Humira. AbbVie expects combined revenues of both Skyrizi and Rinvoq to be more than $15 billion by 2025.

AbbVie Inc. Price

AbbVie Inc. Price
AbbVie Inc. Price

AbbVie Inc. price | AbbVie Inc. Quote

Zacks Rank & Stocks to Consider

AbbVie currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector include Regeneron Pharmaceuticals REGN, Repligen Corporation RGEN and Vertex Pharmaceuticals VRTX. While Regeneron and Repligen each carry a Zacks Rank #1 (Strong Buy) at present, Vertex holds a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Regeneron’s earnings per share estimates for 2021 have increased from $49.91 to $58.89 in the past 60 days. The same for 2022 has risen from $40.91 to $46.57 over the same period. The stock has rallied 32.7% in the year so far.

Repligen’s earnings per share estimates for 2021 have increased from $2.26 to $2.76 in the past 60 days. The same for 2022 has risen from $2.57 to $3.03 over the same period. The stock has rallied 59.7% in the year so far.

Vertex’s earnings per share estimates for 2021 have increased from $11.22 to $12.37 in the past 60 days. The same for 2022 has risen from $12.24 to $13.13 over the same period.


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