Obiltoxaximab

Unassigned

New Medicines

Obiltoxaximab SFL · With antibiotics for treatment of inhaled anthrax due to Bacillus anthracis or for post-exposure prophylaxis of inhaled anthrax when alternative therapies are not appropriate/ unavailable (all ages)

Information

Obiltoxaximab SFL
New molecular entity
SFL Pharmaceuticals Deutschland GmbH
Elusys Therapeutics

Development and Regulatory status

Recommended for approval (Positive opinion)
Recommended for approval (Positive opinion)
Launched
Yes
Yes
Sep 20 · Also has orphan drug status in EU [5].
Sep 20 · In EU, CHMP recommends approval of obiltoxaximab for use in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis. Obiltoxaximab SFL is also indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available [3,5].
Nov 17 · Launched in the US as injection of 100 mg/ml in a single-dose vial. Filing was supported by efficacy data in animal models, safety data from 350 healthy volunteers and efficacy and safety data on intramuscular obiltoxaximab. [2]
Jun 06 · FDA grant orphan drug status.[2]
May 05 · FDA granted Fast Track status.[2]

Category

Monoclonal antibody - binds to free protective antigen (PA) and inhibits the binding of PA, a cell-binding protein and one of the three essential components of anthrax toxin, that are required for anthrax infectivity and entry into cells.
Human anthrax is rare in the UK. In England and Wales only 30 possible cases of anthrax were notified between 1981 and 2015. Infections are more common in countries where the disease is common in animals, eg South and Central America, southern and eastern Europe, Asia, and Africa [1].
With antibiotics for treatment of inhaled anthrax due to Bacillus anthracis or for post-exposure prophylaxis of inhaled anthrax when alternative therapies are not appropriate/ unavailable (all ages)
Intravenous infusion

Trial or other data

Apr 14 · PIII trial completed which investigated the safety, tolerability, pharmacokinetics and immunogenicity of a single i.v. dose of obiltoxaximab in 280 healthy adult volunteers (NCT01929226) in the US. They were randomised 3:1 to receive either obiltoxaximab 16 mg/kg or placebo. Bioavailability and pharmacokinetics was assessed, in addition to immunogenicity. The primary outcome was the no. of participants who experienced adverse events; this was  41.9% in the treatment gp and 38.6% in the placebo gp. Frequently observed adverse events were pruritus and headache. All cause mortality was 0% in both gps. Secondary outcome measures were pharmacokinetic measures. In another trial of 70 volunteers, commonly observed adverse events were infusion site swelling, infusion site pain and infusion site erythema. Repeat administration and use alongside ciprofloxacin did not increase frequency of adverse effects. [2,4]