Obiltoxaximab SFL

obiltoxaximab

Table of contents

Opinion

On 17 September 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation under exceptional circumstances1 for the medicinal product Obiltoxaximab SFL2, 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. The active substance of Obiltoxaximab SFL is obiltoxaximab (ATC code: J06BB22), a monoclonal antibody that binds to the protective antigen (PA) of Bacillus anthracis toxin. Obiltoxaximab thereby inhibits the binding of PA to its cellular receptors, preventing the intracellular entry of the toxin components responsible for the pathogenic effects of anthrax toxin.

The benefits with Obiltoxaximab SFL are its ability to neutralise the PA component of anthrax toxin, which led to increased survival in animal challenge studies.  The most common side effects in healthy human volunteers receiving obiltoxaximab are headache, pruritus, and urticaria.  Hypersensitivity reactions (including rash) occurred in approximately 10% of exposed subjects and anaphylaxis occurred in <1% of exposed subjects.  The safety of obiltoxaximab has been studied only in healthy volunteers.

The full indication is:

Obiltoxaximab SFL is indicated in combination with appropriate antibacterial drugs in all age groups for treatment of inhalational anthrax due to Bacillus anthracis (see section 5.1).

Obiltoxaximab SFL is indicated in all age groups for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available (see section 5.1).

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.


1In 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.

2This 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

Key facts

Name
Obiltoxaximab SFL
Agency product number
EMEA/H/C/005169
International non-proprietary name (INN) or common name
  • obiltoxaximab
Active substance
  • Obiltoxaximab
Therapeutic area
Anthrax
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Date opinion adopted
17/09/2020
Company name
SFL Pharmaceuticals Deutschland GmbH
Status
Positive
Application type
Initial authorisation

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