AbbVie ( ABBV Quick Quote ABBV - Free Report) announced positive top-line data from two phase III studies evaluating its psoriasis drug, Skyrizi (risankizumab) for a new indication — active psoriatic arthritis. Skyrizi is presently approved to treat moderate-to-severe plaque psoriasis.
Top-line data from the KEEPsAKE-1 and KEEPsAKE-2 studies showed that significantly more patients treated with risankizumab (150 mg) 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 versus placebo. The studies included psoriatic arthritis patients who had responded inadequately to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
After 24 weeks of treatment, ACR20 response was achieved in 57% and 51% of the patients in the KEEPsAKE-1 and KEEPsAKE-2 studies, respectively versus 34% and 27% for patients in the placebo group. The candidate also showed significant improvements in skin clearance, physical function and minimal disease activity, which were the studies’ secondary endpoints, at week 24. The safety results in these studies were generally consistent with the known profile of risankizumab in psoriasis patients
AbbVie’s stock has risen 18.6% this year so far compared with an increase of 4% for the
AbbVie has developed Skyrizi in collaboration with privately-held Boehringer Ingelheim. The drug recorded sales of $1.07 billion in the first nine months of 2020 after being launched only in the first half of 2019. Skyrizi is also being developed in phase III study for Crohn’s disease and phase II for ulcerative colitis
Another important new immunology drug in AbbVie’s portfolio is Rinvoq. which is presently approved to treat moderate-to-severe rheumatoid arthritis (RA). Rinvoq is also under review in the United States and EU for ankylosing spondylitis, psoriatic arthritis and atopic dermatitis indications.
Skyrizi and Rinvoq have demonstrated differentiated clinical profiles versus Humira and are expected to lower AbbVie’s dependence on Humira. Importantly, Skyrizi and Rinvoq are performing beyond management expectations and AbbVie expects combined revenues of these two drugs to be approximately $2.2 billion in 2020. With many new indications coming in the next couple of years, sales of these drugs could be higher and have the potential to replace Humira when generics are launched in 2023.
Per settlements with nine manufacturers like
Biogen ( BIIB Quick Quote BIIB - Free Report) /Samsung Bioepis, Amgen ( AMGN Quick Quote AMGN - Free Report) , Sandoz (generic arm of Novartis ( NVS Quick Quote NVS - Free Report) , among others, Humira biosimilars are expected to be launched in the United States in 2023. In the international markets, AbbVie is already facing direct biosimilar competition in Europe and other countries.
AbbVie currently has a Zacks Rank #3 (Hold). You can see
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