Anthim Approved for Inhalation Anthrax
March 18, 2016 – The U.S. Food and Drug Administration approved Elysys Therapautics’ Anthim (obiltoxaximab); a monoclonal antibody that deactivates anthrax toxins, to be used along with antibacterial drugs to treat inhalation anthrax as well as to prevent inhalation anthrax when other preventive measures are not practical. Anthim also makes the list for Strategic National Stockpile of drugs and Medical Supplies needed in a potential widespread emergency. Funding for the development of Anthim came from the Department of Defense, U.S. Department of Health and Human Services, Biomedical Advanced Research, and Development Authority, and the National Institutes of Health. Due to ethical reasons, effectiveness studies for Anthim were only carried out with laboratory animals. Its safety, in particular, was also tested in humans. The recommended utilization of Anthim should be given as one intravenous (IV) infusion over 90 minutes, after a dose of Diphenhydramine. Due to the risks of anaphylaxis associated with Anthim, it is advised that the drug be administered in a facility where the patient can be watched for signs of anaphylaxis and the staff is prepared to handle any potential adverse reactions. Recommended dosing for Anthim dosing is based on total body weight, with adults receiving 16mg per kilogram (Kg) of body weight and children needing higher amounts per Kg. Anthim will be dispensed in single-use 6mL vials, each containing 600mg of Anthim.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.