Elusys Therapeutics has published data from five clinical trials of ANTHIM, which was used to support the marketing approval by the U.S. Food and Drug Administration.
The trials were conducted on 450 adult subjects for the treatment of inhalation anthrax. The results of the ANTHIM trials were published online at Clinical Therapeutics.
"These data, combined with previously reported efficacy data from animal model studies, further support the addition of ANTHIM to the therapeutic armamentarium in the treatment of inhalation anthrax," Elusys President and CEO Elizabeth Posillico said. "Based on the consistent results from five clinical trials in healthy volunteers, the pharmacokinetics of ANTHIM can be considered adequately characterized, a criteria of the Animal Rule."
The FDA gave marketing approval for ANTHIM in March. The medication is indicated for adult and pediatric patients to treat them for inhalational anthrax caused by Bacillus anthracis. When treating these patients, ANTHIM was combined with antibacterial drugs and for prophylaxis of inhalational anthrax when other treatments are unavailable or are not suitable.
Elusys has stated that the use of ANTHIM for prophylaxis only occur when inhalation anthrax outweighs the risk of hypersensitivity and anaphylaxis.