AbbVie’s SKYRIZI Obtains FDA Approval to Treat Active Psoriatic Arthritis

AbbVie (NYSE: ABBV) has received U.S. Food and Drug Administration (FDA) approval for its first-of-its-kind interleukin-23 (IL-23) inhibitor SKYRIZI (risankizumab-rzaa) to treat sufferers of active psoriatic arthritis (PsA). Notably, PsA is a systemic inflammatory disease that affects the skin and joints and affects 30% of patients with psoriasis.

Supporting Data 

The regulator’s approval followed the data from two Phase 3 clinical studies, KEEPsAKE-1 and KEEPsAKE-2. The safety and efficacy profile of SKYRIZI in adults with active PsA was evaluated. These patients included individuals who have had an inadequate response or have been intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Markedly, the data demonstrated that SKYRIZI met the primary endpoint of ACR20 response at week 24 versus placebo. 

Official Comments 

KEEPsAKE clinical trial investigator, Alan J. Kivitz, said, “In the pivotal KEEPsAKE trials, SKYRIZI demonstrated improvements across a number of psoriatic arthritis symptoms, including joint pain, enthesitis and dactylitis. This approval provides both dermatologists and rheumatologists with an option that helps improve skin and joint symptoms in patients with active psoriatic arthritis, alongside a quarterly dosing schedule that may fit their patients’ lifestyle.” 

Wall Street’s Take 

Recently, Barclays analyst Carter Gould reiterated a Hold rating on the stock but increased the price target to $133 from $118. 

Consensus among analysts is a Strong Buy based on 14 Buys versus 3 Holds. The average AbbVie price target of $143.07 implies 8.4% upside potential from current levels. Shares have gained 25% over the past year. 

AbbVie is expected to release its upcoming earnings report for the fourth quarter of 2021 on February 2. 

Smart Score 

AbbVie scores an 8 of 10 from TipRanks’ Smart Score rating system, indicating that the stock has strong potential to outperform market expectations.

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