EU/3/18/2012: Orphan designation for the treatment of epidermolysis bullosa

genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII

Table of contents

Overview

On 16 April 2018, orphan designation (EU/3/18/2012) was granted by the European Commission to IDEA Innovative Drug European Associates Limited, United Kingdom, for genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII (also known as KB103) for treatment of epidermolysis bullosa.

Key facts

Active substance
genetically modified replication-incompetent herpes simplex virus-1 expressing collagen VII
Intended use
Treatment of epidermolysis bullosa
Orphan designation status
Positive
EU designation number
EU/3/18/2012
Date of designation
16/04/2018
Sponsor

IDEA Innovative Drug European Associates (Ireland) Limited

Unit 13 Classon House
Dundrum Business Park
Dundrum Road
Dublin 14
D14 W9Y3
Ireland

E-mail: inquires@krystalbio.com

Update history

Date Update
July 2022 The sponsor’s address was updated in July 2022.
February 2019 The sponsorship was transferred to IDEA Innovative Drug European Associates (Ireland) Limited, Republic of Ireland, in February 2019.

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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