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Bimekizumab authorized for marketing in the EU

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On August 20, 2021, the European Commission authorized marketing of Bimzelx (bimekizumab) in the EU for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy. Bimekizumab is a humanized IgG1 kappa antibody that selectively inhibits IL-17A and IL-17F by binding regions that are common to these pro-inflammatory cytokines, which share ~50% sequence identity and are expressed as homodimers and IL-17A/F heterodimers. Bimekizumab is approved at a recommended dose of 320 mg, administered by two subcutaneous injections every four weeks to week 16 and every eight weeks thereafter. [1]

The decision to grant a marketing approval was supported by results from 3 Phase 3 studies that included an active comparator arm, ustekinumab (Stellara®; BE VIVID study; NCT03370133), adalimumab (Humira®; BE SURE study; NCT03412747), or secukinumab (Cosentyx®; BE RADIANT study; NCT03536884). All three pivotal studies met their co-primary endpoints at Week 16, demonstrating superiority of bimekizumab over the active comparator in certain defined measures (e.g., Psoriasis Area and Severity Index). Clinical responses achieved with bimekizumab at Week 16 were maintained up to one year. [2-4] Coprimary endpoints were also met in the Phase 3 BE READY study (NCT03410992), which investigated the efficacy and safety of bimekizumab in patients with moderate to severe plaque psoriasis compared to placebo. [5]

Bimzelx is the 8th antibody therapeutic to be first approved for marketing in the EU or US in 2021.

  1. European Medicines Agency. Bimzelx public assessment report.
  2. Reich K, Papp KA, Blauvelt A, et al. Bimekizumab versus ustekinumab for the treatment of moderate to severe plaque psoriasis (BE VIVID): efficacy and safety from a 52-week, multicentre, double-blind, active comparator and placebo-controlled phase 3 trial. Lancet. 2021;397(10273):487-498.
  3. Warren RB, Blauvelt A, Bagel J, et al. Bimekizumab versus Adalimumab in Plaque Psoriasis. N Engl J Med. 2021;385(2):130-141.
  4. Reich K, Warren RB, Lebwohl M, Gooderham M, Strober B, Langley RG, Paul C, De Cuyper D, Vanvoorden V, Madden C, Cioffi C, Peterson L, Blauvelt A. Bimekizumab versus Secukinumab in Plaque Psoriasis. N Engl J Med. 2021 Jul 8;385(2):142-152.
  5. Gordon KB, Foley P, Krueger JG, et al. Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase 3 trial. Lancet. 2021;397(10273):475-486.

FDA approves anifrolumab for systemic lupus erythematosus

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On July 30, 2021, the US Food and Drug Administration approved AstraZeneca’s Saphnelo (anifrolumab-fnia) for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE) who are receiving standard therapy. The recommended dosage is 300 mg administered as an intravenous infusion over a 30-minute period every 4 weeks. Saphnelo is undergoing regulatory review for SLE in the EU and Japan.

Anifrolumab (MEDI-546) is an interferon (IFN) alpha receptor 1 (IFNAR1)-specific human IgG1κ antibody. It binds to subunit 1 of IFNAR1, thereby blocking the action of different type I IFNs (IFN-α, IFN-β and IFN-ω). The heavy chain of the antibody incorporates 3 mutations, L234F, L235E, and P331S, to decrease effector functions. Type I IFNs are involved in the pathogenesis of SLE, and ~ 60-80% of adult patients with active SLE express elevated levels of type I IFN-inducible genes.

FDA’s approval was based in part on efficacy and safety data from two TULIP Phase 3 trials and the MUSE Phase 2 trial. In these trials, more patients treated with Saphnelo experienced a reduction in overall disease activity across organ systems, including skin and joints, and achieved sustained reduction in oral corticosteroid use compared to placebo, with both groups receiving standard therapy. Clinical study results from the Phase 3 TULIP-2 and TULIP-1 trials were published in The New England Journal of Medicine and in The Lancet Rheumatology, respectively,  while results from the MUSE Phase 2 trial were published in Arthritis & Rheumatology.

Need help keeping up to date on US and EU approvals?

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US in the Web Resources section of our website.

Tralokinumab granted first approval in the European Union

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The European Commission has approved Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy. The European Commission decision is valid in all European Union Member States, Iceland, Norway, and Liechtenstein.

Tralokinumab is a human IgG4l antibody targeting IL-13, a pleiotropic T helper type 2 cytokine associated with atopic dermatitis and other inflammatory disorders. The antibody interferes with IL-13-mediated signaling by blocking its interactions with both IL-13 receptor α1 and IL-13 receptor α2. Originally identified by Cambridge Antibody Technology and developed by MedImmune as CAT-354, AstraZeneca sold the rights to tralokinumab in dermatology indications to LEO Pharma in 2016.

The marketing applications are supported by data from three Phase 3 studies, ECZTRA 1 (NCT03131648), 2 (NCT03160885), and ECZTRA 3 (NCT03363854). The randomized, double-blind, placebo-controlled, multinational, 52-week ECZTRA 1 and ECZTRA 2 trials evaluated the safety and efficacy of tralokinumab (300 mg SC) as monotherapy in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy. ECZTRA 3 was a double-blind, randomized, placebo-controlled, multinational 32-week study of 380 patients that evaluated the safety and efficacy of tralokinumab (300 mg SC) in combination with topical corticosteroid in adults with moderate-to-severe atopic dermatitis who were candidates for systemic therapy.

The results of the three Phase 3 studies were recently published in the British Journal of Dermatology. [1] The primary outcome measures for the studies included an Investigator’s Global Assessment (IGA) of 0 or 1 and 75% improvement in Eczema Area and Severity Index (EASI 75) at Week 16. At this time point in the ECZTRA 1 and ECZTRA 2 studies, 15.8% and 22.2% of patients who received tralokinumab achieved an IGA score of 0/1 vs. 7.1% and 10.9% of patients who received placebo, respectively. More patients who received tralokinumab also achieved EASI 75 compared to those who received placebo (25.0% vs. 12.7% and 33.2% vs. 11.4% in ECZTRA 1 and ECZTRA 2, respectively). In the ECZTRA 3 study, which included use of topical corticosteroid, 38.9% patients who received tralokinumab achieved IGA 0/1 vs. 26.2% of those who received placebo. EASI 75 was achieved in 56.0% patients who received tralokinumab vs. 35.7% of those who received placebo. [2]

1. Wollenberg A, Blauvelt A, Guttman-Yassky E, Worm M, Lynde C, Lacour JP, Spelman L, Katoh N, Saeki H, Poulin Y, et al. Tralokinumab for moderate‐to‐severe atopic dermatitis: results from two 52‐week, randomized, double‐blind, multicentre, placebo‐controlled phase III trials (ECZTRA 1 and ECZTRA 2). Br J Dermatol. 2020. doi: 10.1111/bjd.19574.

2. Silverberg JI, Toth D, Bieber T, Alexis AF, Elewski BE, Pink AE, Hijnen D, Jensen TN, Bang B, Olsen CK, Kurbasic A, Weidinger S. Tralokinumab plus topical corticosteroids for the treatment of moderate-to-severe atopic dermatitis: results from the double-blind, randomized, multicentre, placebo-controlled phase III ECZTRA 3 trial. Br J Dermatol. 2020. doi: 10.1111/bjd.19573.

Need help keeping up to date on US and EU approvals?

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Aduhelm (aducanumab) approved for the treatment of Alzheimer’s disease.

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On June 7, 2021, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s disease. Developed by Biogen, aducanumab is a human IgG1 antibody that targets anti-amyloid b. Biogen licensed the worldwide rights to aducanumab from Neurimmune in 2007, and has collaborated with Eisai on the global development and commercialization of aducanumab since 2017.

The late-stage development program for Aduhelm consisted of two Phase 3 clinical trials. One study met the primary endpoint, showing reduction in clinical decline. The second trial did not meet the primary endpoint.  In all studies in which it was evaluated, Aduhelm reduced the level of amyloid plaques in the brain in a dose- and time-dependent fashion.  The reduction in amyloid  plaque is considered a surrogate for a reduction in clinical decline. Aduhelm was approved using FDA’s accelerated approval pathway, which can be based on the drug’s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients. A post-approval trial to verify that the drug provides the expected clinical benefit is required.

Need help keeping up to date on US and EU approvals?

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.

Amivantamab granted FDA approval for non-small cell lung cancer

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On May 21, 2021, U.S. Food and Drug Administration approved Rybrevant (amivantamab-vmjw) as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have specific types of genetic mutations: epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Rybrevant received Priority Review and Breakthrough Therapy designation for this indication.

Amivantamab (JNJ-61186372; Janssen Pharmaceutical Companies of Johnson & Johnson) is a human, low-fucose IgG1-based bispecific antibody targeting EGFR and mesenchymal epithelial transition factor (MET) that was created using Genmab’s DuoBody technology. Amivantamab has been shown to function through multiple mechanisms of action in preclinical models of NSCLC with EGFR exon 20 insertion driver mutations, which cause tumor cells to be insensitive to EGFR tyrosine kinase inhibitors.

The efficacy of amivantamab was evaluated in a study of 81 patients with non-small cell lung cancer and EGFR exon 20 insertion mutations whose disease had progressed on or after platinum-based chemotherapy. In the trial population in which all patients received the drug, the overall response rate was 40% and the median duration of response was 11.1 months, with 63% of patients having a duration of response of 6 months or more.

FDA’s review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence. Project Orbis provides a framework for concurrent submission and review of oncology drugs among international partners. For review of amivantamab, the FDA collaborated with the Brazilian Health Regulatory Agency and United Kingdom’s Medicines and Healthcare products Regulatory Agency.

Need help keeping up to date on US and EU approvals?

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. The table, which is located in the Web Resources section of the Society’s website, can be downloaded in Excel format.