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.
This medicine is now known as tosatoxumab.
The sponsorship was transferred to Clinical Network Services (NL) B.V., the Netherlands in March 2019.
In August 2020, Clinical Network Services (NL) B.V.changed name to Scendea (NL) B.V.
The sponsorship was transferred to Marcello Menapace in July 2021.
Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (tosatoxumab)
Treatment of pneumonia caused by Staphylococcus aureus
|Orphan designation status||
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Review of designation
Documents related to this orphan designation evaluation
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
For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
The list of medicines that have received an orphan designation in the EU is available on the European Commission's website: