EU/3/15/1578:

Adenovirus associated viral vector serotype 8 containing the human CNGB3 gene

Overview

On 11 November 2015, orphan designation (EU/3/15/1578) was granted by the European Commission for adenovirus associated viral vector serotype 8 containing the human CNGB3 gene for the treatment of achromatopsia caused by mutations in the CNGB3 gene.

An administrative transfer of sponsorship, to Athena Vision Ltd, United Kingdom, was finalised in January 2016.

In September 2016, Athena Vision Ltd changed name to MeiraGTx UK II Limited.

The sponsorship was transferred to MeiraGTx B.V., The Netherlands in May 2019.

The sponsorship was tranferred to Janssen-Cilag International N.V., Belgium, in June 2021.

Key facts

Active substance
Adenovirus associated viral vector serotype 8 containing the human CNGB3 gene
Intented use
Treatment of achromatopsia caused by mutations in the CNGB3 gene
Date of designation
11/11/2015
Orphan designation status
Positive
EU designation number
EU/3/15/1578

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

Janssen-Cilag International N.V.

Turnhoutseweg 30
2340 Beerse
Antwerp
Belgium
E-mail: RA-RNDUS-JANSSENRND@its.jnj.com

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.

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