AbbVie (ABBV) has announced that it has submitted applications to the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) seeking approval for Rinvoq (upadacitinib) for the treatment of adults and adolescents with moderate to severe atopic dermatitis.
The atopic dermatitis indication applications to the FDA and EMA are supported by data from three pivotal Phase 3 studies.
In all three studies, Rinvoq demonstrated significant improvement in skin clearance and reduction in itch in adults and adolescents with moderate to severe atopic dermatitis compared to placebo.
Rinvoq met the co-primary endpoints including at least a 75% improvement in the Eczema Area Severity Index from baseline and a validated Investigator’s Global Assessment for Atopic Dermatitis score of 0/1 (clear or almost clear) at week 16.
Additionally, more patients treated with either dose of upadacitinib experienced a clinically meaningful reduction in itch, defined as improvement in Worst Pruritus Numerical Rating Scale.
The safety profile of Rinvoq was consistent across the three pivotal Phase 3 studies in atopic dermatitis. No new safety risks were observed in these studies.
“While there have been advancements in care, patients with moderate to severe atopic dermatitis continue to experience relentless itch and skin symptoms that can impact their everyday lives,” said Michael Severino, president of AbbVie. “These submissions are an important step forward in our commitment to providing an additional treatment option for those who struggle with this debilitating and often underappreciated disease.”
Between 20% to 46% of adults with atopic dermatitis have moderate to severe disease. The range of symptoms pose significant physical, psychological and economic burden on individuals impacted by the disease.
Discovered and developed by AbbVie scientists, Rinvoq is a selective and reversible JAK inhibitor that is being studied in several immune-mediated inflammatory diseases. (See Abbvie’s stock analysis on TipRanks).
Shares in ABBV are down 5% year-to-date, but the stock scores a bullish Strong Buy Street consensus. The $111 average analyst price target indicates 32% upside potential lies ahead.
Citigroup analyst Andrew Baum recently raised the stock’s price target to $105 from $98 and reiterated a Buy rating. Baum believes that the “underappreciated revenue and/or durability” upside from the company’s marketed agents Skyrizi, Rinvoq and Imbruvica offsets the current risk from the recently announced congressional subpoena on AbbVie’s drug pricing practices.