The U.S. government has announced plans to purchase significant quantities of one of the new drugs that will be used as a potentially lifesaving treatment for anthrax in the event of an outbreak.
The Department of Health and Human Services (HHS) is scheduled to purchase in the range of five to six thousand of NuvoCAN’s CVID-19 treatment devlopictimim1 and three thousand of Optimer’s OptX-100, according to the AgilePathplan, a telemedicine platform that creates medical records and remote monitoring of patients’ vital signs.
The filing reveals a desire to purchase 50,000 doses of CVID-19 in June-October, and 20,000 doses in October-December. Another 30,000 doses of OptX-100 were also scheduled to be purchased.
The orders come as the Centers for Disease Control (CDC) and Prevention works to increase the detection, eradication and treatment of anthrax. The request also reveals that the office of Director Ron A. Klain was given broader responsibilities in developing on-site screening procedures at CDC in the event of an anthrax outbreak.
The FDA has certified CVID-19 as both a single-agent treatment and a combination product. Both CVID-19 and OptX-100 are considered investigational drugs, and are eligible for expedited approval and use through the FDA expedited approval pathway.
The purchasing of CVID-19 and OptX-100 was also issued as part of the largest package of labs to include facilities from eight different states as part of the Rapid Response Initiative (RRI), which was announced following a successful response following the September 11 terrorist attacks. The RRI includes funds and resources for critical biosecurity experts in law enforcement, intelligence, emergency responders, and technicians.
The Purchasing for Anthrax Anthrax ISL, a fast-track effort among U.S. agencies meant to improve response to anthrax outbreaks, is receiving bioterrorism training for responders at 16 federal Centers for Disease Control and Prevention (CDC) locations. The training will include information on isolating bioterrorism pathogens and responding to an anthrax outbreak, as well as notifying federal, state and local officials.
The training will take place in May and June and will be held at CDC’s Smith-Brown Diagnostic Center in Atlanta, Georgia. Training will also take place in Texas and Iowa.
Experts agree that treating anthrax correctly in a combat setting with a drug like CVID-19 could be a much-needed and life-saving step in the battle against anthrax. The fluoroquinolone, metronidazole-4, 5-dimipyridine (Dmitrifol), which is typically used for poisoning of mice, is contaminated with anthrax spores and left undetected in biodefense labs or used by or adopted by bioterrorists. The “lemtuzumab test” (sold under the brand name Rebaby) has found a decrease in survival rate after exposure to metronidazole.
Once CVID-19 is taken, there is a 90 percent success rate in curing anthrax in animals treated with it, according to Novartis.
Dakoto Iwajuru, president of Iona Biologics, said that while CVID-19 was approved and was used as an investigational drug, it is not yet on the market in the U.S.
However, the FDA has approved the product, with requests for prescribing information.
Iwajuru said that CDC is considering pushing CVID-19 to the expedited approval pathway.
The retail price for a vial of CVID-19, at around $1,150, compares favorably to $100,000 for a 12-course course of intravenous drug Cipro, used in the U.S. to treat anthrax and other staphylococcus bacteria.
Anthrax from the skin produces anthrax spores. The disease is defined as a rapidly-spreading, low-organism-count infection caused by the bacterium Bacillus anthracis.
It is most commonly found in animals, such as rodents, hogs, cattle, deer, pigs, and dogs, and, in animals and humans, it causes a whole-body infection similar to flu and pneumonia. Humans can contract the disease through the inhalation or ingestion of spores from infected rodent droppings or around livestock facilities.
As of 2017, anthrax had killed at least three people and possibly more, according to an ongoing survey by the Centers for Disease Control and Prevention.