EU/3/15/1504: Orphan designation for the treatment of follicular lymphoma

Obinutuzumab

Overview

On 19 June 2015, orphan designation (EU/3/15/1504) was granted by the European Commission to Roche Registration Limited, United Kingdom, for obinutuzumab for the treatment of follicular lymphoma.

Obinutuzumab for treatment of follicular lymphoma has been authorised in the EU as Gazyvaro since 13 June 2016.

The sponsorship was transferred to Roche Registration GmbH, Germany in February 2018.

Key facts

Active substance
Obinutuzumab
Medicine name
Gazyvaro
Intented use
Treatment of follicular lymphoma
Orphan designation status
Positive
EU designation number
EU/3/15/1504
Date of designation
19/06/2015
Sponsor

Roche Registration GmbH
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany
Tel. +49 7624 142892
Fax +49 7624 1015
E-mail: global.eu_regulatory_office@roche.com

Review of designation

During its meeting of 17 to 19 May 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/15/1504 for Gazyvaro (obinutuzumab) as an orphan medicinal product for the treatment of follicular lymphoma. The COMP assessed whether, at the time of addition of a new indication to the marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with follicular lymphoma. The COMP recommended that the orphan designation of the medicine be maintained1.


1 The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with the same therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Gazyvaro (obinutuzumab) for the treatment of follicular lymphoma (PDF/79.9 KB)

    Adopted

    First published: 19/08/2016
    Last updated: 19/08/2016
    EMA/COMP/370418/2016

  • Patients' organisations

    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.

    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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