On March 23, reslizumab (Cinqair®) became the third new monoclonal antibody product to be approved in 2016. Reslizumab targets IL-5, and it was approved by the Food and Drug Administration for use with other asthma medicines for the maintenance treatment of severe asthma in patients aged 18 years and older who have a history of severe asthma attacks (exacerbations) despite receiving their current asthma medicines. A marketing application for reslizumab is undergoing review by the European Medicines Agency.
Ixekizumab: Second mAb approved in 2016
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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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.
Antibodies to watch in 2016
Seven novel antibody therapeutics (begelomab, bezlotoxumab, brodalumab, ixekizumab, obiltoxaximab, sarilumab, reslizumab) are undergoing regulatory review as of December 2015, and thus may gain their first approvals in 2016. Commercial late-stage antibody therapeutics development has exceeded expectations by increasing from 39 candidates in Phase 3 studies as of late 2014 to over 50 as of late 2015. Of these candidates, transitions to regulatory review by the end of 2016 are projected for 8 (atezolizumab, benralizumab, bimagrumab, durvalumab, inotuzumab ozogamicin, lebrikizumab, ocrelizumab, tremelimumab). Other “antibodies to watch” include 15 candidates (bavituximab, bococizumab, dupilumab, fasinumab, fulranumab, gevokizumab, guselkumab, ibalizumab, LY2951742, onartuzumab, REGN2222, roledumab, romosozumab, sirukumab, Xilonix) undergoing evaluation in Phase 3 studies that have estimated primary completion dates in 2016. As evidenced by these therapeutics, the biopharmaceutical industry has a highly active late-stage clinical pipeline that may deliver numerous new products to the global market in the near future.
