Policy & Regulation
Elusys Therapeutics Inc's Obiltoxaximab receives marketing authorization from the EC for the inhalation treatment of anthrax
3 December 2020 -

Therapeutic antibodies company Elusys Therapeutics Inc reported on Wednesday the receipt of approval from the European Commission for the company's monoclonal antibody (mAb) anthrax antitoxin obiltoxaximab for the treatment of inhalations by anthrax.

The company said Obiltoxaximab is indicated for all age groups in combination with antibacterial drugs suitable for the treatment of inhalational anthrax due to Bacillus anthracis as well as post-exposure inhalation anthrax prophylaxis when alternative therapies are not available or appropriate.

This EU approval for obiltoxaximab will automatically become UK marketing authorization on 1 January 2021.

In conjunction, SFL Pharmaceuticals Deutschland GmbH will act as Marketing Authorization Holder (MAH) in the EU and UK. Obiltoxaximab has received approval under the brand name Anthim in the US and Canada. In the EU, obiltoxaximab will be approved under the brand name Obiltoxaximab SFL.

The EC's approval is based on data from the company's studies conducted with funding from US government agencies, including the Biomedical Advanced Research and Development Authority (BARDA), part of the US Office of the Assistant Secretary for Preparedness and Response. Department of Health and Human Services, the National Institutes of Health (NIH) and the US Department of Defense (DoD).