Elusys Therapeutics Receives Health Canada Approval For Anthim
Elusys Therapeutics, Inc. (Elusys) have announced that Health Canada has approved the company's New Drug Submission (NDS) for Anthim (obiltoxaximab for injection), the company's monoclonal antibody (mAb) anthrax antitoxin for the treatment of inhalation anthrax. Anthim is indicated in adult and pediatric patients for the treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs; and for post-exposure prophylaxis of inhalational anthrax due to B. anthracis when alternative therapies are not available or not appropriate.
Anthim was approved under the Extraordinary Use New Drug (EUND) Regulations, leveraging data from previous studies funded by U.S. government agencies, including the Biomedical Advanced Research and Development Authority (BARDA), the National Institutes of Health (NIH), and the U.S. Department of Defense (DoD). The EUND regulations provide a regulatory pathway for products for which collecting clinical information for its intended use in humans is logistically or ethically not possible. Anthim is designated by Health Canada as an innovative drug, giving it eight years of market exclusivity.
"Elusys is pleased to receive Health Canada approval for Anthim, enabling future procurement of this critical medical countermeasure," said , PhD, President and Chief Executive Officer of Elusys. "This is an important step in our efforts to expand availability of Anthim to nations around the world where the U.S. has bilateral relations."
A Marketing Authorization Application (MAA) was filed in 2019 in the European Union under the Centralized Procedure. The application is currently under review. In , Anthim received market clearance by the U.S. Food and Drug Administration (FDA).
"In order to protect public health and enhance national health security, it is critical to maintain a robust supply of treatment options, including antitoxins and other medical countermeasures for rapid deployment and treatment of civilian and military populations," added , MD, MPH, InterimMD Inc.