The FDA approved Anthim injections for treatment of Anthrax on Friday. Anthim (obiltoxaximab) has been synthesized by the drug corporation Elusys Therapeutics, Inc. Inhalational Anthrax is a respiratory tract infection caused by deadly bacteria.
FDA Approved Anthim Injections For Treatment Of Anthrax
According to the FDA, Anthim is the first of its kind as it will help other anti-bacterial drugs. Before Anthim, only anti-bacterial drugs were used to treat the disease, which killed the bacteria. Anthim on the other hand only stops the disease progression. So Anthim will treat the disease alongside the anti-bacterial drugs by neutralizing the damage causing toxins.
Elusys has been working on an anti-inhalation anthrax drug, since the 2001 bioterrorism attack on the U.S. East Coast. In 2002 Elusys started research on the biological component Obiltoxaximab, now tailored into Anthim. In 2014 Elusys gave the first positive response that Anthim could be on its way to FDA approval. The final approval by FDA is a milestone against anthrax related bioterrorism.
What Is Anthim (Obiltoxaximab)?
Anthim (Obiltoxaximab) is a form of monoclonal antibody, also called (mAb) anthrax antitoxin. The injections neutralize toxins released by Bacillus Anthracis. Anthim mainly prevents entry of anthrax toxin into cells.
The U.S. Department of Health and Human Services’ Biomedical Advanced Research helped Elusys to create Anthim. Anthim is given as a single-dose in vials through intravenous (IV) infusion. A single 16 mg/kg IV dose is recommended. $45 million have already been granted to Elusys by the U.S. government to synthesize Anthim for the U.S. Strategic National Stockpile (SNS).
The injections gained approval under FDA’s Animal Rule. The Animal Rule requires strictly controlled animal studies, if human trials are considered dangerous. Trial reliability was centred on the survival of the animals at the end. Finally, animals treated with Anthim survived at the end rather than the one’s treated with the placebo. The drug cocktail containing Anthim resulted in a higher survival rate compared to traditional therapy. Anthim equipped the antibacterial drugs to achieve a higher success rate.
‘This marks a historic milestone for our company, resulting from an unprecedented partnership with several government agencies, to develop a new anthrax antitoxin that will be an important addition to the Strategic National Stockpile (SNS) and help protect the safety of our citizens and emergency personnel in the event of bio-warfare attack,’ said Elizabeth Posillico, PhD, President and Chief Executive Officer of Elusys.
Inhalational Anthrax is believed to be the most dangerous form of Anthrax. So it can be used as a form of biological weapon. The spores can be easily spread by releasing in the air and have resistant properties against destructive chemicals. It makes anthrax a deadly weapon in case of a bioterrorism attack.
The most dangerous incidence of using Anthrax as a biological weapon was back in 2001 in the United States. After the 9/11 attacks, two U.S. Senators and Media agencies in the East Coast were targeted. They received letters filled with a white powder containing the anthrax spores. 11 of the exposed individual fell ill with inhalational anthrax and five of them passed away.
All of the deaths were a result of inhalational anthrax making it the deadliest form of anthrax. The incident resulted in a 7-year investigation by the FBI which finally ended in 2010. The Anthrax attack investigation was also called the Amerithrax investigation. The attack was one of the major reasons why Elusys started developing Anthim in 2002.
The disease inhalational anthrax is a very rare form of anthrax. It is basically a respiratory disease caused by bacterial infection of Bacillus Anthracis. The disease takes effect when people breathe in or inhale the bacterial spores. Exposure to infected animals or contaminated animal products leads to infection.
People working in slaughterhouses, wool mills and tanneries are particularly susceptible to be infected. However, inhalational anthrax is not contagious i.e., it does not spread from person to person through breathing. It only spread through a contaminated animal source. Handling the wool, hair and hides of the infected animals leads to catching the disease.
Raising infected animals or consuming infected meat does not cause inhalational anthrax, but can cause other forms of anthrax. The symptoms of inhalational anthrax includes fever, cough, dizziness, chills, chest pains, stomach pains headache, fatigue etc.
After inhalation the bacteria ‘germinates’ or reproduces itself in the lymph nodes of the human body. It takes 13 to 14 days to replicate but can even take as long as two months. After replication the bacteria starts producing toxins in the body which lead to irreversible tissue damage.
The toxic substances can cause swelling, internal bleeding and the eventual death of tissues. The damage starts from the chest and slowly spreads to other parts of the body. According to the CDC, only 10-15% of normal people with inhalation anthrax survive. With aggressive treatments the survival rate can even increase up to 55%.
Allergic Side Effects
To determine biological safety and side effects of Anthim, it was given to 320 healthy human volunteers. The only side effects were itching, headache, cough, nasal congestion, bruising, hives, swelling and upper respiratory tract infections. In conclusion Anthim does cause allergic reactions or hypersensitivity in some patients, but the benefits outweigh the drawbacks. The drug will carry a Boxed Warning to prepare patients and health care providers beforehand. Besides if Anthim proves to be life-saving in cases of deadly infection, then the temporary side-effects are negligible.
Anthrax Symptoms In Animals
Mammals and some species of birds develop anthrax infection. Most commonly anthrax seizes cattle, pigs, horses and sheep, but the symptoms vary from species to species. In cattle and sheep, temperature, shivering or twitching with a harsh dry cough have been reported. Similarly, blood is found in the dung or the nostrils of the animals. Fits, bright staring eyes, colicky pains and loss of appetite are also reported. Horses and pigs display different symptoms such as swelling in the throat and colic pain in horses.