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Credit Suisse analyst Vamil Divan reiterated an Underperform rating on AbbVie after the FDA further ramped up its focus on biosimilars. In a research note to investors, Divan said he was "intrigued" by the FDA's decision to withdraw its September 2017 Draft Guidance focused on evaluating analytical similarity with biosimilars, and believes the agency will release "more reasonable" guidance in the coming months that will expedite the approval and uptake of biosimilars. AbbVie is most exposed to Biosimilar risk, Divan says, with Humira accounting for about 60% of its total net present value, and is cautious on AbbVie's outlook in front of biosimilar competition in the EU later this year and in the U.S. by 2023.

AbbVie announced positive top-line results from SELECT-GCA, a Phase 3, multicenter, randomized, double-blind, placebo-controlled study, showing upadacitinib in combination with a 26-week steroid taper regimen achieved its primary endpoint of sustained remissiona from week 12 through week 52 in adults with giant cell arteritis. In this study, 46% of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained remission compared to 29 percent of patients receiving placebo in combination with a 52-week steroid taper regimen. Key secondary endpoints were also met, including a higher percentage of patients receiving upadacitinib 15 mg in combination with a 26-week steroid taper regimen achieved sustained complete remissionb from week 12 through week 52 compared to patients receiving placebo in combination with a 52-week steroid taper regimen. A lower percentage of patients experienced at least one disease flare through week 52 in the upadacitinib 15 mg group versus the placebo group. The study results also showed that upadacitinib 7.5 mg did not meet the primary or any of the secondary endpoints.