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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.

FDA approves VYVGARTô (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis

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On December 17, 2021, argenx SE announced that the US Food and Drug Administration approved VYVGARTô (efgartigimod alfa-fcab) for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. Efgartigimod is an IgG1 Fc fragment designed for increased affinity for the neonatal Fc receptor (FcRn). It competes with IgG to occupy FcRn and reduce overall IgG recycling. Efgartigimod was derived from the ABDEG (antibodies that enhance IgG degradation) technology developed by Prof. Sally Ward and colleagues.

FDA’s approval of VYVGART is based on results from the global Phase 3 ADAPT trial, which met its primary endpoint. Trial results demonstrated that significantly more anti-AChR antibody positive gMG patients were responders on the MG-ADL scale following treatment with VYVGART compared with placebo (68% vs. 30%; p<0.0001). There were also significantly more responders on the Quantitative Myasthenia Gravis (QMG) scale following treatment with VYVGART compared with placebo (63% vs. 14%; p<0.0001).

Marketing authorization applications for efgartigimod for the treatment of gMG are currently under review in Japan and the European Union, with anticipated decisions in the first quarter and second half of 2022, respectively.

FDA grants emergency use authorization to anti-SARS-COV-2 mAb Evusheld

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On December 8, 2021, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab and administered together) for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and pediatric individuals (12 years of age and older weighing at least 40 kilograms [about 88 pounds]).

Evusheld, comprising the combination of 2 human anti-SARS-CoV-2 IgG1k antibodies, was derived from B cells from convalescent patients after infection with SARS-CoV-2. Discovered by Vanderbilt University Medical Center, the antibodies bind to distinct sites on the SARS-CoV-2 spike protein. These antibodies were licensed to AstraZeneca in June 2020, and then engineered with mutations that extend half-life (YTE) and reduce Fc receptor and complement C1q binding (L234F, L235E, P331S). The primary data supporting the EUA came from the PROVENT clinical study, which is assessing the safety and efficacy of a single 300 mg dose of AZD7442 compared to placebo for the prevention of COVID-19. At the primary analysis, the study data showed AZD7442 reduced the risk of developing symptomatic COVID-19 by 77% (95% CI: 46, 90), compared to placebo.

Evusheld is the 4th anti-SARS-CoV-2 antibody product granted an EUA. See our COVID-19 Biologics Tracker for information about other anti-SARS-CoV-2 antibodies.

WHO retires -mab suffix

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Without fanfare, the World Heath Organization has announced a new INN monoclonal antibody (mAb) nomenclature scheme that divides the substances that contain an immunoglobulin variable domain into four groups, three for monospecific immunoglobulins and one for bi- and multi-specific immunoglobulins, independent of their type, shape and form. The new INN mAb
nomenclature scheme is used for all substances that contain an immunoglobulin variable domain that binds to a defined target, and that is composed of only immunoglobulin-derived pharmacologically active components. The suffix is preceded by an infix that indicates the target class.

Overview

  • Group 1 -tug for unmodified immunoglobulins
    Monospecific full length and Fc unmodified immunoglobulins of any class. Molecules which might occur as such in the immune system. including: IgG, IgA, IgM, IgD, IgE; only allelic variants; Glycoengineering without mutation; C-terminal lysine deletion without any other mutation in the Fc region
  • Group 2 -bart for antibody artificial
    Monospecific full length immunoglobulins with engineered constant domains (CH1/2/3).
    Monospecific full length immunoglobulins that contain any point mutation introduced by engineering for any reason anywhere (hinge, new glycan attachment site, mixed allelic variants which would not occur in nature, altered complement binding, altered FcRn binding, altered Fc-gamma receptor binding, etc.)
    e.g. IGHG4 with S>P mutation, stabilized IgA
  • Group 3 -mig for multi-immunoglobulin
    Bi- and multi-specific immunoglobulins regardless of the format, type or shape (full length, full length plus, fragments)
  • Group 4 -ment for fragment
    All monospecific domains, fragments of any kind, derived from an immunoglobulin variable domain (all monospecific constructs that do not contain an Fc domain)

Additional details are found here.

Antibodies to Watch in 2022

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The On Demand version of this webinar is now available.

In “Antibodies to Watch in 2022”, Drs. Janice Reichert, Alicia Chenoweth and Silvia Crescioli discuss key events in antibody therapeutics development that occurred in 2021 and forecast events that might occur in 2022. The COVID-19 pandemic continued to pose challenges and opportunities to the healthcare system, but companies forged ahead with development plans, resulting in record numbers of antibody therapeutics in late-stage clinical studies and in regulatory review. Globally, regulatory agencies approved a record number of novel antibody-based products, including anti-SARS-CoV-2 antibodies. The speakers provide details of 2021 events and trends in the development of antibody therapeutics projected for 2022.

View On Demand webinar