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US approval for mogamulizumab

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On August 8, 2018, the U.S. Food and Drug Administration (FDA) approved Poteligeo (mogamulizumab-kpkc) for intravenous use for the treatment of adult patients with relapsed or refractory mycosis fungoides (MF) or Sézary syndrome (SS) after at least one prior systemic therapy. The diseases are subtypes of cutaneous T-cell lymphoma (CTCL), which is a rare and difficult-to-treat type of non-Hodgkin lymphoma. The FDA had previously granted mogamulizumab Breakthrough Therapy and Orphan Drug designations, and the biologics license application for mogamulizumab received a priority review.

FDA’s approval was based on an open-label, multi-center, randomized Phase 3 clinical trial (NCT01728805) of 372 patients with relapsed MF or SS who received either mogamulizumab or vorinostat. Study sites were located in the US, Europe, Japan and Australia. Median progression-free survival was 7.6 months for patients administered mogamulizumab compared to 3.1 month for patients taking vorinostat in this clinical trial.

Developed by Kyowa Kirin, mogamulizumab is a humanized glyco-engineered monoclonal antibody that binds to CC chemokine receptor type 4 on cancer cells. Mogamulizumab was produced using Kyowa Hakko Kirin’s proprietary POTELLIGENT® platform, which produces antibodies with low / no fucose content. Such antibodies have increased affinity to FcγRIIIa (CD16), and enhanced antibody-dependent cell-mediated cytotoxicity activity. Mogamulizumab’s first approval, in 2012, was granted by the Japanese Ministry of Health, Labour and Welfare for treatment of patients with relapsed or refractory CCR4-positive adult T-cell leukemia-lymphoma.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. As of Aug 8, a total of 5 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 11 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table in either PDF or Excel formats, located in the Members Only section.

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First approval for erenumab

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On May 17, 2018, the U.S. Food and Drug Administration approved erenumab-aooe (Aimovig) for the preventive treatment of migraine in adults. Erenumab is a human monoclonal antibody that targets calcitonin gene-related peptide (CGRP) receptor, thereby blocking the activity of CGRP, which is involved in migraine attacks. The treatment is given by once-monthly subcutaneous injections.

The approval was based on data from three clinical trials that compared erenuman-aooe to placebo. Over 2000 participants were included in the studies. In the first study (STRIVE, NCT02456740), which included 955 participants with a history of episodic migraine, patients administered erenumab-aooe experienced, on average, one to two fewer monthly migraine days than those on placebo over a 6 month period. In the second study (ARISE, NCT02483585), which included 577 patients with a history of episodic migraine, patients administered erenumab-aooe experienced, on average, one fewer migraine day per month than those on placebo over a 3 month period. The third study, which evaluated 667 patients with a history of chronic migraine, patients treated with erenumab-aooe experienced, on average, 2.5 fewer monthly migraine days than those receiving placebo over a three month period.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. As of May 17, a total of 4 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 10 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table, located in the Members Only section.

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First approval for tildrakizumab-asmn

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On March 20, 2018, the US Food and Drug Administration (FDA) approved tildrakizumab-asmn (Ilumya) for treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Tildrakizumab, a humanized IgG1 kappa monoclonal antibody, targets IL-23p19 and blocks the interaction of IL-23 with its receptor, thereby inhibiting release of pro-inflammatory cytokines and chemokines.

FDA approval was supported by results from two Phase 3 trials (reSURFACE 1 and 2) in which patients were randomized to tildrakizumab 200 mg, tildrakizumab 100 mg, or placebo (2:2:1; reSURFACE 1), or to tildrakizumab 200 mg, tildrakizumab 100 mg, placebo, or etanercept 50 mg (2:2:1:2; reSURFACE 2). In these trials, the tildrakizumab 200 mg and 100 mg doses were well tolerated and found to be efficacious compared with placebo and etanercept in the treatment of patients with moderate-to-severe chronic plaque psoriasis. The results of both studies were published in The Lancet in July 2017.

The Antibody Society maintains a comprehensive table of approved monoclonal antibody therapeutics and those in regulatory review in the EU or US. As of March 23, a total of 3 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 8 that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table, located in the Members Only section.

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First approval for ibalizumab-uiyk

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On March 6, 2018, the US Food and Drug Administration (FDA) approved ibalizumab-uiyk (Trogarzo) for adult patients infected with human immunodeficiency virus (HIV) who were previously treated with multiple HIV medications and whose HIV infections are resistant currently available therapies. Ibalizumab-uiyk, a humanized IgG4 monoclonal antibody, is a CD4 domain 2-directed post-attachment HIV-1 inhibitor. The marketing application was granted Breakthrough Therapy, Fast Track and Priority Review designations, and ibalizumab was granted an orphan drug designation by FDA. Theratechnologies Inc. and TaiMed Biologics, Inc. have an agreement to market and distribute Trogarzo in the US and Canada.

The product is administered intravenously (IV) as a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks after dilution in 250 mL of 0.9% sodium chloride. The safety and efficacy of ibalizumab-uiyk were evaluated in the Phase 3 TMB-301 study (NCT02475629), which was a single arm, multicenter clinical trial conducted in 40 heavily treatment-experienced HIV-infected patients with multidrug resistant HIV-1. At Week 25, viral load <50 was achieved in 43% of patients, while 55% and 48% of patients had a ≥ 1 log10 reduction in viral load and a ≥ 2 log10 reduction in viral load, respectively. The most common adverse reactions reported in at least 5% of subjects were diarrhea, dizziness, nausea, and rash. In total, 292 patients with HIV-1 infection were exposed to ibalizumab-uiyk IV infusion during clinical studies. Additional prescribing information for the drug can be found here.

The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in the EU or US. As of March 7, 2018, a total of 2 mAbs have been granted first approvals in either the US or EU in 2018, and marketing applications for a total of 9 antibody therapeutics that have not yet been approved in either the EU or US are undergoing review in these regions. Please log in to access the table, located in the Members Only section.

Not a member? Please join! Membership is free for students and employees of the Society’s corporate sponsors.

Antibodies new to the market, and exiting

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On February 23, 2018, Kyowa Hakko Kirin Co. Ltd and its partner Ultragenyx Pharmaceutical Inc. announced that a conditional marketing authorization had been granted in the European Union (EU) for burosumab (Crysvita) as a treatment for X-linked hypophosphatemia in children 1 year of age and older, and adolescents with growing skeletons. Burosumab is a human IgG1 monoclonal antibody that binds to and inhibits the activity of fibroblast growth factor 23, thereby reducing loss of phosphate from the kidney and other metabolic abnormalities, and ameliorating bone changes that are a hallmark of the disease. The marketing approval in the EU is the first for burosumab. A biologics license application is undergoing review by the US Food and Drug Administration (FDA), and an action on the application is expected by April 17, 2018.

On February 27, 2018, Roche announced that emicizumab (Hemlibra®) had been approved in the EU for routine prophylaxis of bleeding episodes in people with hemophilia A with factor VIII inhibitors. Emicizumab, a bispecific IgG4 mAb targeting Factors IXa and X that originated at Chugai Pharmaceutical Co. Ltd., was approved by the FDA on November 16, 2017.

On March 2, 2018, Biogen and AbbVie announced the voluntary worldwide withdrawal of marketing authorizations for ZINBRYTA® (daclizumab) for relapsing multiple sclerosis (MS). The withdrawal coincides with an urgent review by the European Medicines Agency (EMA) of inflammatory brain disorder in 8 patients, and follows a 2017 review by EMA of reports of liver injury. Due to the risk of serious liver damage, EMA limited use of Zinbryta to MS patients who had tried at least two other disease modifying treatments and could not be treated with any other such treatments. ZINBRYTA® had been marketed in the EU, US, Switzerland, Canada and Australia.

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