On 5 March 2012, orphan designation (EU/3/12/968) was granted by the European Commission to Envestia Limited, United Kingdom, for human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (also known as KBSA301) for the treatment of pneumonia caused by Staphylococcus aureus.
The sponsorship was transferred to Global Regulatory Limited, United Kingdom, in November 2017.
EU/3/12/968: Public summary of opinion on orphan designation: Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin for the treatment of pneumonia caused by Staphylococcus aureus (PDF/131.88 KB)
First published: 06/07/2012
Last updated: 16/10/2014
Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin
|Disease / condition||
Treatment of pneumonia caused by Staphylococcus aureus
|Date of decision||
|Orphan decision number||
Review of designation
The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.
Sponsor's contact details
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.