EU/3/07/501: Orphan designation for the treatment of ovarian cancer

Olaparib

Overview

Please note that this product was withdrawn from the Community register of designated orphan medicinal products in March 2018 upon request of the marketing authorisation holder at the time of the granting of a change to the terms of the marketing authorisation.

On 6 December 2007, orphan designation (EU/3/07/501) was granted by the European Commission to AstraZeneca AB, Sweden, for olaparib for the treatment of ovarian cancer.

Olaparib has been authorised in the EU as Lynparza since 16 December 2014.

Key facts

Active substance
Olaparib
Medicine name
Lynparza
Intended use
Treatment of ovarian cancer
Orphan designation status
Withdrawn
EU designation number
EU/3/07/501
Date of designation
06/12/2007
Sponsor

AstraZeneca AB
151 85  Södertälje
Sweden
Tel. +44 (0)1625 514776 (AstraZeneca UK Limited)
E-mail: olaparib@astrazeneca.com

Review of designation

In March 2018 the Committee for Orphan Medicinal Products reviewed again the orphan designation of Lynparza at the time of the granting of a change to the terms of the marketing authorisation.

The sponsor formally requested the withdrawal of the orphan designation prior to the Committee's final opinion. More information is available in the withdrawal assessment report – orphan maintenance.

During its meeting of 11 to 13 November 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/07/501 for Lynparza (olaparib) as an orphan medicinal product for the treatment of ovarian cancer. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness 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 ovarian cancer. The COMP recommended that the orphan designation of the medicine be maintained*.


*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 a comparable 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: Lynparza (olaparib) for the treatment of ovarian cancer (PDF/87.64 KB)

    Adopted

    First published: 19/01/2015
    Last updated: 28/05/2018
    EMA/COMP/685740/2014

  • 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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