EU/3/12/968: Orphan designation for the treatment of pneumonia caused by Staphylococcus aureus

Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (tosatoxumab)

Overview

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.

Key facts

Active substance
Human monoclonal antibody targeting Staphylococcus aureus alpha-toxin (tosatoxumab)
Intended use
Treatment of pneumonia caused by Staphylococcus aureus
Orphan designation status
Positive
EU designation number
EU/3/12/968
Date of designation
05/03/2012
Sponsor

Marcello Menapace
Via Due Giugno 6 
20094 Corsico (MI) 
Italy 
E-mail: mmscltd@gmail.com

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

Patients' organisations

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:

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