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AbbVie's (ABBV) Skyrizi Gets FDA Nod for Psoriatic Arthritis

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AbbVie, Inc. (ABBV - Free Report) announced that the FDA approved a second indication for its inflammatory drug, Skyrizi (risankizumab), to treat patients with active psoriatic arthritis.

Please note that Skyrizi was first approved to treat moderate-to-severe plaque psoriasis in 2019. Active psoriatic arthritis is the second FDA-approved indication for the drug. The drug is approved for both these indications in Europe as well.

The FDA approval for the label expansion of Skyrizi to include active psoriatic arthritis was based on positive top-line data from two pivotal studies — KEEPsAKE-1 and KEEPsAKE-2. Data from these studies demonstrated that the proportion of patients who achieved the primary endpoint of ACR20 response or at least a 20% reduction in the number of both tender and swollen joint counts at week 24 following treatment with Skyrizi was significantly higher compared to treatment with placebo. The drug also showed significant improvements in skin clearance, physical function and minimal disease activity in the pivotal studies.

Data from these pivotal studies supported the potential of Skyrizi in improving several psoriatic arthritis symptoms, which include joint pain, enthesitis and dactylitis.

AbbVie’s stock has risen 19.4% in the past year compared with an increase of 9.7% for the industry.

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Sykrizi is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23, a cytokine, which is involved in inflammatory processes.

AbbVie is developing Skyrizi in collaboration with Boehringer Ingelheim, with AbbVie leading the global development and commercialization of Skyrizi. The companies are currently seeking another label expansion of Skyrizi to include patients with Crohn’s disease. Regulatory applications seeking approval for the drug as a potential treatment for Crohn’s disease are under review in the United States and Europe.

AbbVie remains focused on strengthening its focus on Skyrizi and its other inflammatory 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 Roche (RHHBY - Free Report) , Pfizer (PFE - Free Report) and Vertex Pharmaceuticals (VRTX - Free Report) . While Roche and Pfizer sport a Zacks Rank #1 (Strong Buy), Vertex carries a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

Roche’s earnings per share estimates for 2021 have increased from $3.04 to $3.12 in the past 30 days.

Shares of Roche have risen 7.5% in the past year.

Pfizer’s earnings estimates per share for 2022 have increased from $5.66 to $5.80 in the past 30 days. Shares of Pfizer have risen 41.6% in the past year.

Earnings of Pfizer beat estimates in three of the last four quarters and missed expectations on one occasion, the average surprise being 10.85%.

Vertex’s earnings per share estimates for 2022 have improved from $13.32 to $13.35 in the past 30 days.

Earnings of Vertex beat estimates in three of the last four quarters and missed expectations once, the earnings surprise being 8.00%, on average.