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First approval for fremanezumab-vfrm

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On September 14, 2018, the U.S. Food and Drug Administration (FDA) approved fremanezumab-vfrm (Ajovy) for the preventive treatment of migraine in adults. The drug may be administered as either 225 mg monthly, or 675 mg quarterly, subcutaneous doses. Fremanezumab-vfrm is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP), thereby blocking the binding of the ligand to its receptor. The monoclonal antibody erenumab-aooe (Aimovig), which was approved by the FDA in May 2018 for the preventive treatment of migraine in adults, targets CGRP receptor, rather than the ligand. Marketing applications for galcanezumab, another monoclonal antibody that targets CGRP, are undergoing review by FDA and the European Medicines Agency.

The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of September 14, a total of 9 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 7 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 moxetumomab pasudotox-tdfk

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On September 13, 2018, the U.S. Food and Drug Administration approved moxetumomab pasudotox-tdfk (Lumoxiti) for the treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who have received at least two prior systemic therapies, including treatment with a purine nucleoside analog. The drug is a recombinant immunotoxin targeting CD22 composed of an IgG1 kappa variable fragment fused to a truncated form of Pseudomonas exotoxin PE38. In a pivotal, multicenter, open-label study of moxetumomab pasudotox involving 80 patients (79% males; median age, 60.0 years), the durable complete response (CR) rate was 30%, CR rate was 41%, and the objective response rate (CR and partial response) was 75%. Due to the severity and rarity of the disease, the FDA granted the application Fast Track and Priority Review designations and the molecule received US Orphan Drug designation.

The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of Sep 13, a total of 8 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 in either PDF or Excel formats, located in the Members Only section.

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Save the date: AIRR Community Meeting IV at the University of Genoa

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AIRR Community Meeting IV: Bridging the Gaps
11-15 May 2019, University of Genoa, Italy

Invitation and Meeting Agenda

Information on past AIRR meetings

The theme of this meeting, “Bridging the Gaps” addresses technological gaps between the amounts of accumulated data and our ability to process them, and the need for more involvement of stakeholder communities (industry, clinicians, patent communities) for uptake of the standards developed by the AIRR Community. We have confirmed two outstanding Keynote speakers – Dr. Sai Reddy from ETH Zurich and Dr. Antonio Lanzavecchia from IRB Bellinzona. Two planned panel discussions will include representatives from other institutions and companies that work with AIRR-seq data. In addition, two “challenge” sessions are planned to address the above-mentioned gaps. Two pre-meeting workshops will be available to teach the basics of immunology, and of AIRR-seq data analysis for beginners. Also planned are two poster sessions; and two tool and software demos sessions.

 

Stay tuned for more information!

Appreciation of reviewer contributions

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Peer Review Week is a global event celebrating the essential role that peer review plays in maintaining quality in scientific communication. The 4th Peer Review Week is being held September 10 – 15, 2018, focusing on diversity in peer review.

Peer review is an essential part of the manuscript evaluation process, which ensures that relevant, high-quality articles are selected for publication in our affiliated journals, mAbs and PEDS. We would like to thank all reviewers who have contributed their insights and advice for improvement of manuscripts submitted for publication in the journals. These experts invest substantial time and effort in the review of submitted manuscripts, and we sincerely appreciate their valuable input!

First approval for caplacizumab

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On September 3, 2018 Sanofi announced that the European Commission granted a marketing approval for caplacizumab (Cablivi), a bivalent single-domain Nanobody targeting von Willebrand factor, as a treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP). During episodes of this rare, life-threatening blood clotting disorder, microclots can form, leading to low platelet counts, ischemia and organ dysfunction in aTTP patients. Caplacizumab was granted Fast Track designation in the US and orphan drug designations in the US and EU for the treatment of aTTP. The biologics license application (BLA) for caplacizumab is undergoing a priority review at the US Food and Drug Administration (FDA). A first action by FDA is expected by February 6, 2019. Caplacizumab was developed by Ablynx, a Sanofi company.

The approval of caplacizumab in the European Union was based in part on the Phase 3 HERCULES study (NCT02553317), a placebo-controlled, randomized study to evaluate the efficacy and safety of caplacizumab in more rapidly restoring normal platelet counts as a measure of the prevention of further microvascular thrombosis. Positive results from this study were announced in October 2017. The HERCULES study recruited 145 patients with an acute episode of aTTP who were randomized 1:1 to receive either caplacizumab or placebo in addition to standard-of-care treatment, which was daily plasma exchange (PEX) and immunosuppression. Patients were administered a single IV bolus of 10 mg caplacizumab or placebo followed by daily SC dose of 10 mg caplacizumab or placebo until 30 days after the last daily PEX. Depending on the response, the treatment could be extended for additional 7-day periods up to a maximum of 28 days. The primary endpoint (time to platelet count response) and several secondary endpoints of HERCULES study were met. In particular, there was a statistically significant reduction in time to platelet count response, with, at any given time, patients treated with caplacizumab 50% more likely to achieve platelet count response;  a 74% relative reduction in the percentage of patients with aTTP-related death, a recurrence of aTTP, or at least one major thromboembolic event during the study drug treatment period; and a 67% relative reduction in the percentage of patients with aTTP recurrence during the overall study period. A 3-year Phase 3 follow-up study (NCT02878603) of patients who completed the HERCULES study is in progress.

The Antibody Society maintains a comprehensive table of approved mAb therapeutics and those in regulatory review in the EU or US. As of Sep 3, a total of 7 antibody therapeutics had been granted first approvals in either the US or EU in 2018, and marketing applications for another 9 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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