Subscribe or Manage Preferences

March 2016 - In the News - FDA Updates

On Friday, March 18, the U.S. Food and Drug Administration approved Anthim (obiltoxaximab) injection to treat inhalational anthrax in combination with appropriate antibacterial drugs. Anthim is also approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

Inhalational anthrax is a rare disease that can occur after exposure to infected animals or contaminated animal products, or as a result of an intentional release of anthrax spores. It is caused by breathing in the spores of the bacterium Bacillus anthracis. When inhaled, the anthrax bacteria replicate in the body and produce toxins that can cause massive and irreversible tissue injury and death. Anthrax is a potential bioterrorism threat because the spores are resistant to destruction and can be spread by release in the air.

“As preparedness is a cornerstone of any bioterrorism response, we are pleased to see continued efforts to develop treatments for anthrax,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in FDA’s Center for Drug Evaluation and Research.

Anthim is a monoclonal antibody that neutralizes toxins produced by B. anthracis. Anthim was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.

Anthim’s effectiveness for treatment and prophylaxis of inhalational anthrax was demonstrated in studies conducted in animals based on survival at the end of the studies. More animals treated with Anthim lived compared to animals treated with placebo. Anthim administered in combination with antibacterial drugs resulted in higher survival outcomes than antibacterial therapy alone.

The safety of Anthim was evaluated in 320 healthy human volunteers. The most frequently reported side effects were headache, itching (pruritus), upper respiratory tract infections, cough, nasal congestion, hives, and bruising, swelling and pain at the infusion site.

Anthim carries a Boxed Warning alerting patients and health care providers that the drug can cause allergic reactions (hypersensitivity), including a severe reaction called anaphylaxis. Anthim should be administered in settings where patients can be monitored and treated for anaphylaxis. However, given that anthrax is a very serious and often deadly condition, the benefit of Anthim for treating anthrax is expected to outweigh this risk.

Anthim was developed by Elusys Therapeutics, Inc. of Pine Brook, New Jersey, in conjunction with the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority.

US Food and Drug Administration. FDA approves new treatment for inhalation anthrax. Updated March 21, 2016.

Related Items
Once-Daily Injection Approved for Patients with Type 2 Diabetes
July 2016 - In the News published on July 29, 2016 in FDA Updates
First Oral Regimen FDA Approved for Treatment of Chronic HCV
June 2016 - In the News published on June 29, 2016 in FDA Updates
FDA Approves First Generic Version of Crestor for Multiple Indications in Adults
May 2016 - In the News published on May 25, 2016 in FDA Updates
Nuplazid Approved for Psychosis-Associated Hallucinations in Patients with Parkinson’s Disease
May 2016 - In the News published on May 25, 2016 in FDA Updates
FDA Enhances Warnings for Serious Risks of Opioid Analgesics Abuse
April 2016 - In the News published on April 26, 2016 in FDA Updates
FDA Approves Briviact to Treat Partial Onset Seizures
March 2016 - In the News published on March 21, 2016 in FDA Updates
FDA Approves First Coagulation Factor-Albumin Fusion Protein to Treat Patients with Hemophilia B
March 2016 - In the News published on March 21, 2016 in FDA Updates
FDA Approves Integra Omnigraft Dermal Regeneration Matrix to Treat Diabetic Foot Ulcers
January 2016 - In the News published on January 12, 2016 in FDA Updates
FDA Approves Basaglar, the First “Follow-On” Insulin Glargine Product to Treat Diabetes
January 2016 - In the News published on January 6, 2016 in FDA Updates
FDA Approves Wearable Defibrillator for Children at Risk for Sudden Cardiac Arrest
January 2016 - In the News published on January 6, 2016 in FDA Updates
Last modified: March 24, 2016
  • American Health & Drug Benefits
  • The Journal of Hematology Oncology Pharmacy
  • Lynx CME
  • The Oncology Pharmacist

Search