The Antibody Society

the official website of the antibody society

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

You are here: Home / Archives for approved antibodies

FDA approves Solensia (frunevetmab) for osteoarthritis pain in cats

by

On January 13, 2022, the U.S. Food and Drug Administration (FDA) approved Solensia (frunevetmab), the first monoclonal antibody (mAb) new animal drug approved by the FDA for use in any animal species. Solensia™ is approved for the control of pain associated with osteoarthritis in cats.

Developed by Zoetis Inc., frunevetmab is a felinized immunoglobulin G mAb that targets nerve growth factor. Similar to humanization, felinization is a process in which all regions of a murine antibody are replaced with feline counterparts except for the complementarity-determining regions. Substantial evidence of effectiveness was demonstrated by the results of two field studies in cats with naturally occurring osteoarthritis. The endpoints used to evaluate the effectiveness of Solensia™ were observer-reported measures conducted by either owners (assessment of the cat’s activities before development of osteoarthritis, as well as before and after treatment) or veterinarians (orthopedic examinations before and after treatment).

Solensia™ is given by subcutaneous injection once a month and is dosed by weight range. Cats are given the full contents of 1 or 2 vials based on body weight to target a minimum dose of 1 mg/kg. Each vial contains 7 mg of frunevetmab.

At least one other mAb, lokivetmab (Cytopoint), is approved for veterinarian use in the US.  Manufactured by Zoetis, the product is used to treat atopic dermatitis in dogs, but it was approved by the US Department of Agriculture, not FDA. More information on FDA’s Center for Veterinary Medicine and the New Animal Drug Application (NADA) process can be found here.

FDA approves 10 antibody-based therapeutics in 2021

by

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

by

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.

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

by

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.

Anti-SARS-CoV-2 antibody therapeutics Ronapreve and Regkirona approved in the EU

by

On November 11, 2021, the European Medicines Agency’s human medicines committee recommended authorizing anti-SARS-CoV-2 antibody therapeutics Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19.

  • The Committee recommended authorizing Ronapreve for treating COVID-19 in adults and adolescents (from 12 years of age and weighing at least 40 kilograms) who do not require supplemental oxygen and who are at increased risk of their disease becoming severe. Ronapreve can also be used for preventing COVID-19 in people aged 12 years and older weighing at least 40 kilograms. The company that applied for authorization of Ronapreve was Roche Registration GmbH.
  • The Committee recommended authorizing Regkirona for treating adults with COVID-19 who do not require supplemental oxygen and who are also at increased risk of their disease becoming severe. The applicant for Regkirona was Celltrion Healthcare Hungary Kft.

On November 12, 2021, the European Commission approved both products.