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AbbVie Inc. ABBV announced that it has submitted regulatory applications to the FDA and the European Medicines Agency (EMA), seeking approval for Skyrizi (risankizumab), for a new indication – active psoriatic arthritis.
Skyrizi is presently approved to treat moderate-to-severe plaque psoriasis both in the United States and Europe.
The regulatory filings for psoriatic arthritis were based on data from two pivotal phase III studies, namely, KEEPsAKE-1 and KEEPsAKE-2. These studies evaluated Skyrizi in the given patient population. Data from the same showed that treatment with Skyrizi led to improved skin and joint symptoms, and physical function. Significantly a greater number of patients who were treated with Skyrizi achieved the primary endpoint of ACR20 response at week 24 as compared to placebo. The studies included psoriatic arthritis patients who had responded inadequately to biologic therapy and/or non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
Notably, the safety profile of Skyrizi in the above-mentioned studies was similar to the safety profile of Skyrizi in plaque psoriasis indication, with no new safety risk being observed.
Shares of AbbVie have lost 1.8% so far this year compared with the industry’s decrease of 0.9%.
We note that AbbVie has developed Skyrizi in collaboration with privately held Boehringer Ingelheim. The company is also developing the drug in late-stage studies for psoriasis, Crohn's disease and ulcerative colitis as well. In January 2021, positive data was announced from Crohn's disease studies.
The news of the regulatory filings for Skyrizi in psoriatic arthritis comes as a major respite for AbbVie, as the company suffered a setback when the FDA extended the review period for two supplemental new drug applications (sNDA) for another important new immunology drug, Rinvoq (upadacitinib), within span of a month.
The two sNDAs are seeking label expansion of Rinvoq for treating moderate-to-severe atopic dermatitis and for treating active psoriatic arthritis. The FDA stretched the review period by three months for both the sNDAs.
We note that Skyrizi, along with Rinvoq, might be the catalyst for AbbVie’s growth in the long run and could offset the potential decline in key drug, Humira’s sales following the launch of its biosimilars in the United States, scheduled for 2023. Meanwhile, in the EU, several biosimilars of Humira have been already unveiled by the likes of Amgen AMGN, Biogen BIIB and Novartis’ NVS generic subsidiary, Sandoz, which has already hurt international sales of Humira.
Hence, successful development of Skyrizi and Rinvoq in ongoing clinical studies, followed by potential label expansions, will be key to AbbVie’s long-term growth, as these drugs can offset the loss of Humira sales in the days ahead.
AbbVie currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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