The Antibody Society

the official website of the antibody society

An international non-profit supporting antibody-related research and development.

FDA approves 10 antibody-based therapeutics in 2021

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The US Food and Drug Administration approved a total of 10 novel antibody-based therapeutics in 2021. Of the newly approved products, 4 are treatments for cancer (endometrial, non-small cell lung, and cervical cancers, as well as B-cell lymphoma) and 6 are treatments for non-cancer indications (hypercholesterolemia, Alzheimer’s disease, systemic lupus erythematousus, asthma, generalized myasthenia gravis, and atopic dermatitis).

The products are:

  • Evkeeza (evinacumab-dgnb) approved 2/11/2021 to treat homozygous familial hypercholesterolemia
  • Jemperli (dostarlimab-gxly) approved 4/22/2021 to treat endometrial cancer
  • Zynlonta (loncastuximab tesirine-lpyl) approved 4/23/2021 to treat certain types of relapsed or refractory large B-cell lymphoma
  • Rybrevant (amivantamab-vmjw) approved 5/21/2021 to treat a subset of non-small cell lung cancer
  • Aduhelm (aducanumab-avwa) approved 6/7/2021 to treat Alzheimer’s disease
  • Saphnelo (anifrolumab-fnia) approved 7/30/2021 to treat moderate-to severe systemic lupus erythematousus along with standard therapy
  • Tivdak (tisotumab vedotin-tftv) approved 9/20/2021 to treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
  • Tezspire (tezepelumab-ekko) approved 12/17/2021 to treat severe asthma as an add-on maintenance therapy
  • Vyvgart (efgartigimod alfa-fcab) approved 12/17/2021 to treat generalized myasthenia gravis
  • Adbry (tralokinumab-ldrm), approved 12/27/2021 to treat moderate-to-severe atopic dermatitis

Links to further information for these products, including approval letters and labels, can be found here.

Wondering what might be approved in 2022? The Antibody Society maintains a table of antibody therapeutics in regulatory review in the US or European Union. The table can be found here.

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.

Season’s Greetings

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As the end of the year draws nears, we would like to thank our members, sponsors, partners, and many volunteers for their participation and contributions. With this help, we had a very productive year. In particular, we co-organized two Symposia in 2021, and launched our Career Shorts interviews and webinar series on Antibody Discovery & Development, Commercializing Antibody Therapeutics, and Adaptive Immune Receptor Repertoires.

In case you missed either Symposia, recordings from our Emerging Immunotherapeutics for Ovarian Cancer Symposium (co-organized with the Ovarian Cancer Research Alliance) and Emerging Cancer Therapies Leveraging Gamma-Delta Effector T cells Symposium (co-organized with LAVA Therapeutics) are available On Demand on our YouTube channel.

The Career Shorts interviews are also available on our YouTube channel. In this series, scientists and individuals working within the world of antibodies discuss the experiences that have shaped their careers. In sharing their experiences and advice, we aim to empower the next generation of scientists and leaders working in this field to make confident and informed decisions. Career Shorts is the creation of an exceptionally talented volunteer, Raquel Barroso Ferro.

We hope you will join us in our activities in 2022. In particular, The Adaptive Immune Receptor Repertoire (AIRR) Community of The Antibody Society will hold their 6th meeting during May 16-19, 2022. The “Exploring New Frontiers” meeting will be held in person in La Jolla, CA. The AIRR Community is a research-driven group that is organizing and coordinating stakeholders in the use of next-generation sequencing technologies to study antibody/B-cell and T-cell receptor repertoires.

Our volunteer experts in antibody engineering, Drs. Alicia Chenoweth and Silvia Crescioli, will apply their formidable knowledge of this area to create a searchable table of antibody therapeutics in late-stage clinical studies that will appear online in Q1 2022. Their very useful searchable table of antibody therapeutics that are approved or in review in the European Union or United States is already online.

In addition, we are planning a Symposium on Biopharmaceutical Informatics, tentatively scheduled for September 2022, and we will start a new Graduate Student/Post-doc Research Competition. When available, details for these new programs will be posted on our website and sent via email to members.

Our best wishes to you and yours for a wonderful holiday and a happy new year in 2022!

Xevudy (sotrovimab) approved in the EU for COVID-19

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On December 17, 2021, GlaxoSmithKline plc and Vir Biotechnology, Inc. announced that the European Commission has granted a marketing authorization to Xevudy (sotrovimab) for the early treatment of COVID-19. Sotrovimab is now approved in the European Union for the treatment of adults and adolescents (aged 12 years and over and weighing at least 40kg) with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19. Sotrovimab, a human anti-SARS-CoV-2 IgG1 antibody derived from the B cell of a COVID-19 survivor, was engineered to achieve high concentration in the lungs and to have an extended half-life.

The marketing application included data from the randomized, double-blind, placebo-controlled Phase 1/2/3 COMET-ICE trial (NCT04545060), which evaluated the effects of sotrovimab in non-hospitalized adults with mild-to-moderate COVID-19 symptoms and a positive SARS-CoV-2 test result. Patients received a single intravenous dose of 500 mg sotrovimab or placebo. Study results showed that treatment with sotrovimab resulted in a 79% reduction in all-cause hospitalizations for more than 24 hours or death due to any cause by Day 29 compared to placebo, meeting the primary endpoint of the trial. In total, 30 (6%) of the 529 patients in the placebo arm progressed, compared to six (1%) of the 528 patients receiving sotrovimab.

Sotrovimab is authorized for emergency use in the US, conditional or provisional marketing authorizations in Great Britain, Australia, and Saudi Arabia, as well as temporary authorizations in other countries. Sotrovimab is administered as a 500-milligram single IV dose given over 30 minutes by health care providers. The product has, however, also been formulated for IM administration. In the randomized, open-label COMET-TAIL Phase 3 trial, which achieved its primary endpoint, IM administration of sotrovimab was non-inferior to IV administration for the early treatment of mild-to-moderate COVID-19 in high-risk, non-hospitalized adults and adolescents (12 years of age and older).

FDA approves Tezspire™ (tezepelumab-ekko) for severe asthma

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On December 17, 2021, Amgen announced that the U.S. Food and Drug Administration approved Tezspire™ (tezepelumab-ekko) for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with severe asthma. Tezepelumab (AMG157, MEDI-9929) is a human IgG2 antibody that targets a cytokine, thymic stromal lymphopoietin, that plays a key role in asthma inflammation. The drug was developed by Amgen in collaboration with AstraZeneca.

The approval was based in part on data from the randomized, placebo-controlled Phase 3 NAVIGATOR study (NCT03347279), which evaluated the effects of tezepelumab in adults and adolescents with severe uncontrolled asthma. In this study, patients received tezepelumab (210 mg; n=529) or placebo (n=532) SC every 4 weeks for 52 weeks. The primary outcome measure of the study, the annualized asthma exacerbation rate from baseline to Week 52, was met. For the tezepelumab group, the annualized rate of asthma exacerbations was 0.93 (95% CI, 0.80 to 1.07), while the rate was 2.10 (95% CI, 1.84 to 2.39) with placebo (rate ratio, 0.44; 95% CI, 0.37 to 0.53; P<0.001). Overall, data from the study indicated that, compared to those administered placebo, patients who received tezepelumab had fewer exacerbations and better lung function, asthma control, and health-related quality of life.104 A pre-specified exploratory analysis showed that tezepelumab reduced the annualized asthma exacerbation rate in patients with nasal polyps by 86% (95% CI: 70, 93) and 52% (95% CI: 42, 61) in those without nasal polyps over 52 weeks compared to placebo given with standard of care.

Marketing applications for Tezspire are under regulatory review in the EU, Japan and several other countries around the world.