A total of 15 antibody therapeutics were granted a first approval in the US during 2014-2015. Approximately half (53%) of these products were approved as treatments for cancers, including non-small cell lung cancer (necitumumab, nivolumab), melanoma (nivolumab, pembrolizumab), gastric cancer (ramucirumab), multiple myeloma (daratumumab, elotuzumab), acute lymphoblastic leukemia (blinatumomab) and neuroblastoma (dinutuximab). To aid development planning, we determined the mean and median elapsed time from entry into clinical study to first US approval for 7 of these 8 products. Dinutuximab was excluded because a substantial amount of the development was done by government or non-profit organizations. The mean (median) development time for the 7 products was 8.6 (8.9) years. The product with the shortest development time (4.6 years) was pembrolizumab (Keytruda®), which was the first approved antibody that targets the immune checkpoint PD-1. Pembrolizumab had FDA’s breakthrough therapy designation and orphan product designation, and its marketing application received a priority review and accelerated approval. The accelerated approval program allows FDA to approve a drug that treats a serious or life-threatening disease based on clinical data showing the drug has an effect on a surrogate endpoint reasonably likely to predict clinical benefit to patients, but confirmatory clinical trials must be conducted after approval.
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Reslizumab: Third mAb approved in 2016
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.
WHO’s Open Session on INN to be held on April 12, 2016
The World Health Organization (WHO) recently introduced new definitions for the assignment of antibody international nonproprietary names (INN). Linear protein sequence is now used to define humanness, which is a substantial change in the method by which therapeutic antibodies were previously classified as chimeric, humanized or human. The new definitions are scientifically flawed, provide results that are inconsistent with names of many existing antibody therapeutics, and do not consider advances in antibody technology and antibody development experience.
The Antibody Society will represent the Antibody Community at large at the WHO’s Open Session at the 62nd consultation on INN for pharmaceutical substances in Geneva on April 12, 2016, and we will request modifications that address the problems with the new system.
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The Antibody Society’s presentation at the WHO’s Open Session on April 12, 2016 is available to Society members. Please log in to access the presentation, located on the Presentations page in the Members Only section.
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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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