Nyxthracis (previously Obiltoxaximab SFL)

Withdrawn

This medicine's authorisation has been withdrawn

obiltoxaximab

Overview

On 2 August 2024 the European Commission withdrew the marketing authorisation under exceptional circumstances for Nyxthracis (obiltoxaximab) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, SFL Pharmaceuticals Deutschland GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons. 

Nyxthracis was granted marketing authorisation under exceptional circumstances in the EU on 18 November 2020 for treatment of inhalational anthrax due to Bacillus anthracis, in combination with appropriate antibacterial drugs, and for post-exposure prophylaxis of inhalational anthrax when alternative therapies are not appropriate or are not available. The medicinal product was subject to annual re-assessment of the marketing authorisation under exceptional circumstances. 

The European Public Assessment Report (EPAR) for Nyxthracis is updated to indicate that the marketing authorisation is no longer valid.

Obiltoxaximab SFL : EPAR - Medicine overview

Reference Number: EMA/506632/2020

Obiltoxaximab SFL : EPAR - Risk-management-plan summary

Product information

Nyxthracis : EPAR - Product information

Nyxthracis (previously Obiltoxaximab SFL) : EPAR - All authorised presentations

Product details

• Name of medicine:
  Nyxthracis (previously Obiltoxaximab SFL)
• Active substance:
  nyxthracis
• International non-proprietary name (INN) or common name:
  obiltoxaximab
• Therapeutic area (MeSH):
  Anthrax
• Anatomical therapeutic chemical (ATC) code:
  J06BB22

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

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).

Authorisation details

• EMA product number:
  EMEA/H/C/005169
• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation holder:
  SFL Pharmaceuticals Deutschland GmbH

  Marie-Curie-Strasse 8; 79539 Lörrach; Germany

• Opinion adopted:
  17/09/2020
• Marketing authorisation issued:
  18/11/2020
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Nyxthracis (previously Obiltoxaximab SFL) : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Obiltoxaximab SFL : EPAR - Public assessment report

AdoptedReference Number: EMA/524933/2020

Obiltoxaximab SFL : Orphan maintenance assessment report (initial authorisation)

AdoptedReference Number: EMA/OD/0000037218

CHMP summary of positive opinion for Obiltoxaximab SFL

AdoptedReference Number: EMA/CHMP/460994/2020