FDA Approves Adalimumab-adbm
On Aug. 29, the FDA approved Cyltezo (adalimumab-adbm), a biosimilar to Humira (adalimumab).1 Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis and ankylosing spondylitis, and moderate to severe plaque psoriasis. The treatment has also been approved for moderate to severe polyarticular juvenile idiopathic arthritis in patients age four years and older, moderate to severe active adult Crohn’s disease and moderate to severe active ulcerative colitis.
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Cyltezo is not yet commercially available, and its maker, Boehringer Ingelheim, is currently engaged in patent litigation with AbbVie, which manufactures Humira.
According to Eli Lilly and Co. and Incyte Corp., the makers of baricitinib, the new drug application for baricitinib will be refiled with the FDA before the end of January 2018.2 This resubmission will included new safety and efficacy data. Baricitinib is a once-daily oral investigational drug for treating patients with moderate to severe RA.
In April 2017, baricitinib’s potential approval to treat RA in the U.S. stalled when the FDA sent a complete response letter to the previous new drug application. The FDA declined to approve the treatment, citing that additional clinical data were needed to determine the most appropriate doses and the need for additional data to further characterize safety concerns.3 Baricitinib was approved for use in the European Union in February 2017 and in Japan in July 2017.
Additionally, baricitinib is being studied to treat atopic dermatitis and systemic lupus erythematosus. Phase 3 clinical trials for psoriatic arthritis are scheduled to begin in 2018.
Cyltezo was approved as a prefilled syringe to treat multiple chronic inflammatory diseases, including moderate to severe active RA, active psoriatic arthritis & ankylosing spondylitis, & moderate to severe plaque psoriasis.
FDA Committee Approves Tofacitinib for PsA
On Aug. 3, the Arthritis Advisory Committee of the FDA voted 10–1 to recommend the approval of the proposed dose of tofacitinib for treating adults with active psoriatic arthritis (PsA). Supplemental new drug applications for 5 mg tofacitinib taken twice daily and extended-release 11 mg tofacitinib taken once daily are pending for this indication.4,5
The FDA’s final decision on whether to approve tofacitinib for PsA is anticipated by December 2017.
Bimekizumab Investigational for Psoriasis
Bimekizumab is a monoclonal antibody designed to potently and selectively neutralize both interleukin (IL) 17A and IL-17F cytokines. In the Phase 2b BE ABLE study, the safety, efficacy, pharmacokinetics and pharmacodynamics of bimekizumab were compared with placebo in adult patients with moderate to severe chronic plaque psoriasis.6
The study met the primary objective of establishing dose response for bimekizumab and demonstrated significant efficacy compared with placebo. At Week 12, 79% of bimekizumab-treated patients achieved at least 90% skin clearance in the Psoriasis Area and Severity Index (PASI90). A secondary efficacy objective was complete skin clearance at Week 12 as measured by PASI100. Up to 60% of bimekizumab-treated patients achieved this endpoint.
The safety profile of bimekizumab showed no new safety signals. The most common adverse events observed were nasopharyngitis and upper-respiratory tract infection. Phase 3 studies are currently planned.
Michele B. Kaufman, PharmD, BCGP, is a freelance medical writer based in New York City and a pharmacist at New York Presbyterian Lower Manhattan Hospital.
- Boehringer Ingelheim Pharmaceuticals Inc. News release: Boehringer Ingelheim Pharmaceuticals Inc. receives FDA approval for Cyltezo (adalimumab-adbm), a biosimilar to Humira, for the treatment of multiple chronic inflammatory diseases. 2017 Aug 29.
- Eli Lilly and Co. News release: Lilly to file baricitinib resubmission to U.S. FDA before end of January 2018. 2017 Aug 30.
- Eli Lilly and Co. News release: U.S. FDA issues complete response letter for baricitinib. 2017 Apr 14.
- Pfizer Inc. News release: FDA advisory committee votes in favor of Xeljanz (tofacitinib citrate) for the treatment of active psoriatic arthritis. 2017 Aug 3.
- Walsh N. FDA panel says yes to tofacitinib for PsA—clear efficacy for symptoms, but radiographic progression benefit remains unclear. Medpage Today. 2017 Aug 3.
- UCB. News release: Bimekizumab demonstrates skin clearance in phase 2b psoriasis study with first monoclonal antibody neutralizing both IL-17A and IL-17F. 2017 Jul 21.