EU/3/08/610

About

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
Disease / condition
Treatment of medullary thyroid carcinoma
Date of decision
06/02/2009
Outcome
Positive
Orphan decision number
EU/3/08/610

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.

Sponsor's contact details

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

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.

How useful was this page?

Add your rating