AbbVie Inc. ABBV announced that it has filed a new drug application (“NDA”) to the FDA and a marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”) for its oral investigational JAK inhibitor, upadacitinib. The company is seeking approval of upadacitinib for the treatment of adult patients with moderate to severe rheumatoid arthritis (“RA”).
The regulatory submissions were 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 the studies, upadacitinib met all primary and secondary endpoints.
Data from the SELECT study showed that treatment with upadacitinib, both as a monotherapy and in combination with conventional synthetic DMARDs, led to improved symptoms of RA, better physical function and inhibited radiographic progression.
Shares of AbbVie were up 2.2%, following the announcement of the news of Thursday. However, the stock has plunged 11.7% year to date, against the industry’s increase of 1.6%.
Approval and successful commercialization of upadacitinib are critical for long-term growth at AbbVie, especially as biosimilar competition looms for its blockbuster RA drug, Humira.
Humira accounts for around 65% of AbbVie’s revenues. The drug generated sales of $15 billion in the first nine months of 2018, an increase of 10.9% year over year. However, biosimilar competition for the drug could hurt sales for the company.
Though biosimilar versions of Humira are already approved by the FDA, per settlements with several companies biosimilar entry in the United States is scheduled for 2023. However, in the EU, Amgen AMGN, Biogen BIIB and Sandoz’s biosimilars were launched in October this year, while others like Momenta, Pfizer PFE and Fresenius Kabi will launch their versions as soon as they get EMA’s approval.
Notably, other than rheumatoid arthritis, upadacitinib is also being evaluated in a mid-stage study for giant cell arteritis, and late-stage studies for Crohn’s disease, psoriatic arthritis, ulcerative colitis and atopic dermatitis.
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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