CHMP recommends Obiltoxaximab SFL to treat anthrax.- SFL Pharmaceuticals Deutschland GmbH.

The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances for the medicinal product Obiltoxaximab SFL, intended for the treatment or post-exposure prophylaxis of inhalational anthrax. The applicant for this medicinal product is SFL Pharmaceuticals Deutschland GmbH. Obiltoxaximab SFL will be available as 100 mg/ml concentrate for solution for infusion. In exceptional circumstances, an authorisation may be granted subject to certain specific obligations, to be reviewed annually. This happens when the applicant can show that they are unable to provide comprehensive data on the efficacy and safety of the medicinal product, due to the rarity of the condition it is intended for, limited scientific knowledge in the area concerned, or ethical considerations involved in the collection of such data. This product was designated as orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.