EU/3/08/610: Orphan designation for the treatment of medullary thyroid carcinoma

Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt (cabozantinib)

Overview

This medicine is now known as cabozantinib.

On 6 February 2009, orphan designation (EU/3/08/610) was granted by the European Commission to PPD Global Ltd, United Kingdom, for Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt for the treatment of medullary thyroid carcinoma.

The sponsorship was transferred to TMC Pharma Services Ltd, United Kingdom, in August 2011 and subsequently to Ipsen Pharma, France, in September 2016.

Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt has been authorised in the EU as Cometriq since 21 March 2014.

Key facts

Active substance
Cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt (cabozantinib)
Medicine name
Cometriq
Intented use
Treatment of medullary thyroid carcinoma
Orphan designation status
Positive
EU designation number
EU/3/08/610
Date of designation
06/02/2009
Sponsor

Ipsen Pharma
65 Quai Georges Gorse
92100 Boulogne-Billancourt
France
Tel. + 33 1 58 33 54 38
www.ipsen.com/en/contact-us

Review of designation

During its meeting of 7-9 January 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/08/610 for Cometriq (cabozantinib)1 as an orphan medicinal product for the treatment of medullary thyroid carcinoma. 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 and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained2.


1Previously known as cyclopropane-1,1-dicarboxylic acid [4-(6,7-dimethoxy-quinolin-4-yloxy)-phenyl]-amide (4-fluoro-phenyl)-amide, (L)-malate salt).
2The 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: Cometriq (cabozantinib) for the treatment of medullary thyroid carcinoma (PDF/80.79 KB)

    Adopted

    First published: 26/03/2014
    Last updated: 26/03/2014
    EMA/COMP/4640/2014

  • 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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