AbbVie Inc. (ABBV - Free Report) announced that the FDA has accepted its new drug application (NDA) for its oral investigational JAK inhibitor, upadacitinib, and also granted a priority review to the same. The company is seeking an approval for upadacitinib for treating adult patients with moderate to severe rheumatoid arthritis (RA). A decision from the regulatory body is expected in third-quarter 2019.
AbbVie used a priority review voucher to expedite the review of upadacitinib’s NDA. The FDA generally assigns a priority review designation to drugs with potential of providing significant improvements in the safety and effectiveness of treatment and prevention or diagnosis of a serious disease.
The NDA submission was based on encouraging data from the phase III SELECT study, which evaluated more than 4000 patients across five phase III studies on RA. In all studies, upadacitinib met every primary and secondary endpoint.
Last December, AbbVie filed the NDA for upadacitinib with respect to RA. The candidate is also under review in the EU for the same indication.
Shares of AbbVie have plunged 31.7% in the past year against the industry’s increase of 7.8%.
Notably, apart from rheumatoid arthritis, upadacitinib is being evaluated in a mid-stage study for giant cell arteritis and late-stage analyses for Crohn’s disease, psoriatic arthritis, ulcerative colitis and atopic dermatitis.
Both approval and successful commercialization of upadacitinib are critical for long-term growth of AbbVie, especially as biosimilar competition looms for its blockbuster RA drug, Humira.
Humira accounts for around 61% of AbbVie’s revenues. The drug generated sales of $19.9 billion in 2018, reflecting an increase of 8.2% year over year. However, on fourth-quarter earnings call, management stated that biosimilar competitors in the EU are offering more aggressive discounts than AbbVie anticipated, which severely hurt Humira’s international sales. In 2019, the company expects a drop of 30% or $2 billion in international Humira sales.
In the United States, Humira biosimilars are expected to be launched in 2023. In the EU, Amgen (AMGN - Free Report) , Biogen (BIIB - Free Report) and Novartis’ (NVS - Free Report) generic subsidiary — Sandoz’s — biosimilars were unveiled last October.
AbbVie currently carries 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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