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FDA approves Adtralza® (tralokinumab) for atopic dermatitis

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On December 27, 2021, the US Food and Drug Administration approved Adtralza® (tralokinumab) for the treatment of moderate-to-severe atopic dermatitis in adults 18 years or older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. Tralokinumab had previously been approved in the European Union, in June 2021, for the treatment of moderate-to-severe atopic dermatitis in adult patients who are candidates for systemic therapy.

Tralokinumab is a human IgG4 antibody that interferes with IL-13-mediated signaling by blocking its interactions with both IL-13 receptor α1 and IL-13 receptor α2. The recommended dose is 300 mg administered subcutaneously every 2 weeks, with a loading dose of 600 mg on day 1, and the dose of 300 mg every 4 weeks for patients who achieve clear or almost clear skin after 16 weeks of treatment.

The approvals were supported by data from two Phase 3 monotherapy efficacy and safety studies (ECZTRA 1 (NCT03131648) and ECZTRA 2 (NCT03160885)), as well as a Phase 3 combination therapy efficacy and safety study (ECZTRA 3 (NCT03363854)). These studies included over 1900 patients who received either an initial dose of 600 mg tralokinumab (four 150 mg injections) on day 1, followed by 300 mg every 2 weeks up to Week 16, or they received matching placebo. Patients who responded to tralokinumab were re-randomized at Week 16 and administered tralokinumab maintenance subcutaneous injection regimen every 4 weeks for 36 weeks. In the ECZTRA 3 study, patients received concomitant topical corticosteroids on active lesions as needed. Tralokinumab was administered by subcutaneous injection in the studies. The primary endpoints, the proportion of patients with eczema area and severity index-75 at Week 16 and the proportion of patients with an Investigator’s Global Assessment score of 0 or 1 at Week 16, were met in the three pivotal studies; however, the European Medicines Agency noted that the majority of patients enrolled in the two monotherapy studies did not respond to treatment.

Adtralza is the 13th antibody therapeutic to be first approved for marketing in the EU or US in 2021. Explore our searchable table of antibody therapeutics approved in the EU or US for details.

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 Uplizna (inebilizumab-cdon) for NMOSD

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On June 11, 2020, the U.S. Food and Drug Administration approved Uplizna (inebilizumab-cdon) for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4)-antibody positive. This rare disease primarily affects the optic nerves and spinal cord. Uplizna is a humanized anti-CD19 monoclonal antibody developed by Viela Bio. By targeting CD19, Uplizna depletes CD19+ B cells and plasmablasts responsible for the production of autoantibodies directed against AQP4, thereby ameliorating symptoms of the disease.

The effectiveness of inebilizumab was demonstrated in the Phase 2/3 N-MOmentum trial (NCT02200770). This study enrolled 230 patients with and without the AQP4-IgG antibody who were randomized 3:1 to receive either 2 doses of 300 mg of inebilizumab as a monotherapy or placebo at Day 1 and Day 15, and then followed for a total of 28 weeks. The primary endpoint (time to first attack) and a majority of the secondary endpoints of the study were met. Of patients in the anti-AQP4 antibody positive group, 89% remained relapse-free during the post-treatment period, compared to 58% of the patients taking placebo. There was no evidence of a benefit in patients who were anti-AQP4 antibody negative. Inebilizumab demonstrated a favorable safety and tolerability profile, with an adverse event rate similar to placebo.

Uplizna is the second antibody therapeutic to be approved in the US for NMOSD. FDA approved Soliris (eculizumab) injection for intravenous use for the treatment of NMOSD in adult patients who are anti-aquaporin-4 (AQP4) antibody positive in June 2019. Soliris, which targets C5 was first approved by FDA in 2007 for paroxysmal nocturnal hemoglobinuria. A biologics license application for anti-IL6R satralizumab as a possible treatment for NMOSD is currently under review at FDA. More information about antibody therapeutics approved in the US and EU, and those in regulatory review, can be found here.

Antibody therapeutics for immune-mediated disorders

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Antibody impressionPatients’ choice in antibody therapeutics for common immune-mediated disorders such as psoriasis and rheumatoid arthritis (RA) is set to substantially increase in 2017. As of December 1, 2016, marketing applications for 10 antibody therapeutics are being evaluated by either the US Food and Drug Administration (FDA) or European Medicines Agency (EMA) for possible first approvals in the US or EU, respectively. Of these, five (brodalumab, dupilumab, sirukumab, sarilumab, and guselkumab) are being considered as treatments for immune-mediated disorders.

Brodalumab (LUMICEF®) is a human anti-IL-17 receptor A mAb that inhibits biological activity of IL-17A, IL-17F and other IL-17s. The product was granted a first marketing approval from the Ministry of Health, Labour and Welfare in Japan on July 4, 2016 for the treatment of psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma. The FDA’s action date for the biologics license application (BLA) is February 16, 2017. A marketing authorization application for brodalumab in psoriasis is undergoing evaluation by EMA. Guselkumab, an IgG1 mAb that targets the IL-23 p19 subunit, is undergoing review by FDA and EMA as a treatment for plaque psoriasis. Dupilumab (Dupixent®), an anti-IL-4Ra IgG4 mAb, is undergoing review by FDA for atopic dermatitis. The mAb has Breakthrough Therapy designation for this indication, and the BLA was granted a priority review. FDA’s action date for the application is March 29, 2017. Sirukumab is a human anti-IL-6 mAb being evaluated by EMA, FDA and the Ministry of Health, Labour and Welfare for the treatment of adult patients with moderately to severely active RA. Sarilumab, a human IgG1 targeting IL-6R, is undergoing review by EMA, FDA and the Ministry of Health, Labour and Welfare in Japan for the treatment of adult patients with moderately to severely active RA. The BLA submitted to FDA has undergone a first review; deficiencies identified were detailed in a complete response letter.

The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the US or EU. Please log in to access the table, located in the Members Only section.

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