On March 22, ixekizumab (Taltz®) became the second monoclonal antibody product to be granted a first approval in 2016. Ixekizumab targets interleukin-17A, and it was approved by the Food and Drug Administration for treatment of adults with moderate-to-severe plaque psoriasis. A decision by the European Commission on marketing in the European Union is pending; in February 2016, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for ixekizumab for the treatment of moderate-to-severe plaque psoriasis in adults in the European Union who are candidates for systemic therapy.
Obiltoxaximab: First mAb approved in 2016
On March 18, obiltoxaximab (ANTHIM®) became the first monoclonal antibody to be approved in 2016. Obiltoxaximab targets the protective antigen of Bacillus anthracis, and it was approved by the Food and Drug Administration for the treatment of inhalational anthrax due to B. anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate. Administered intravenously, the product is indicated in both adult and pediatric patients. Efficacy studies in animal models of inhalational anthrax served as the basis for the effectiveness of obiltoxaximab in humans.
A total of 8 additional antibody therapeutics are now undergoing their first regulatory review in the European Union and the Unites States, suggesting that the number of approvals for new antibody products in 2016 may meet or exceed the record set in 2015. The Antibody Society maintains a comprehensive table of approved antibody therapeutics and those in regulatory review in these regions. Information about the antibody target, format and year of first approval are included in the table. Please log in to access the table, located in the Members Only section.
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Overview of the antibody therapeutics clinical pipeline now available!
Antibody therapeutics research and development by the biopharmaceutical industry has undergone remarkable expansion in the past ~ 5 years. Over 100 novel antibodies entered first clinical studies in 2015, and the overall clinical pipeline now includes ~480 antibodies. Importantly for patients, these molecules are progressing through the phases of clinical testing, and being approved for marketing. Over 50 antibody therapeutics for a variety of diseases are in Phase 3 studies. A record number (9 new products) were granted first marketing approvals in the United States or European Union in 2015, and the evidence suggests that a larger number may be approved in 2016. A new presentation now available to Society members shows the number of novel antibodies that entered clinical studies recently, how many are in the three clinical phases, and which antibodies might be approved in 2016. Log in to get the presentation. Not a member? Please join!
‘Antibodies to watch in 2016’ now free
The current late-stage clinical pipeline includes over 50 antibody therapeutics that are listed in the latest installment of the ‘Antibodies to watch’ article series. ‘Antibodies to watch in 2016’ is now freely available on the mAbs website.
mAbs is a journal of the Society, and a special subscription rate of US $63 is available for Society members. To receive the special rate, contact the publisher Taylor & Francis at 1 (800) 354-1420 (Fax: (215) 207-0046) or customerservice@taylorandfrancis.com
The INNs and outs of antibody international nonproprietary names
Recently, the World Health Organization (WHO) introduced new definitions for the assignment of antibody international nonproprietary names (INN). The modifications that already have been effectuated change the way in which therapeutic antibodies are classified as chimeric, humanized and human antibodies. Unfortunately, the new definitions have several major limitations that are unworkable – click here for Paul Carter’s summary.
The Antibody Society intends to represent the Antibody Community at large at an Open Session of the WHO in Geneva on April 12, 2016, and request urgent modifications that address the problems with the new system. To be able to influence the WHO, we need your support. You can support our effort by agreeing to the statement here and provide your name and information.
