Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 61 |
| INN | Obiltoxaximab |
| Status | Approved |
| Drug code(s) | ETI-204 |
| Brand name | Anthim |
| mAb sequence source | mAb chimeric |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | B. anthracis (PA) |
| Indications of clinical studies | Inhalational anthrax |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Approved EU, US |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | February 24, 2005 |
| Start of Phase 2 | |
| Start of Phase 3 | July 09, 2013 |
| Date BLA/NDA submitted to FDA | March 20, 2015 |
| Year of first approval (global) | 2016 |
| Date of first US approval | March 18, 2016 |
| INN, US product name | Obiltoxaximab |
| US or EU approved indications | Anthrax (treatment of inhalational anthrax due to Bacillus anthracis in combination with appropriate antibacterial drugs, and for prophylaxis of inhalational anthrax when alternative therapies are not available or are not appropriate) |
| Company | Elusys |
| Licensee/Partner | None |
| Comments about company or candidate | Obiltoxaximab is manufactured in a murine NS0 cell line. Approval by the European Commission announced by Elusys Therapeutics, Inc. on December 2, 2020. Obiltoxaximab is approved under the brand name Anthim® in the U.S. and Canada. In the EU obiltoxaximab will be approved under brand name Obiltoxaximab SFL. Sep 2020: The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances for the medicinal product Obiltoxaximab SFL2, intended for the treatment or post-exposure prophylaxis of inhalational anthrax. The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH. The full indication is: Obiltoxaximab SFL is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis. BLA submitted March 20, 2015. Three safety and tolerability studies have completed enrollment (as of Feb 2014). AH104 was carried out between July 9, 2013 and November 29, 2013, AH109 between July 23, 2013 and April 19, 2014, and AH110 between October 29, 2013 and April 9, 2014. Fast-Track status and Orphan Drug Designation by the FDA. Development supported with federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100201000026C, the National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Health (NIH), and the Department of Health and Human Services (HHS). ETI-204 is the only anthrax anti-toxin in advanced stages of development that is formulated as a solution and is being investigated for both IV and IM administration. IND filed Feb 24, 2005. (https://www.accessdata.fda.gov/drugsatfda_docs/nda/2016/125509Orig1s000MedR.pdf) |
| Full address of company | 4 Century Drive, Suite 260, Parsippany, NJ 07054, United States North America United States of America https://pitchbook.com/profiles/company/40461-76 |
High-affinity, humanized and deimmunized (according to July 2012 press release)
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |