EU/3/13/1999

About

On 13 November 2013, orphan designation (EU/3/13/1199) was granted by the European Commission to Bayer HealthCare AG, Germany, for sorafenib tosylate for the treatment of follicular thyroid cancer.

In May 2014, the sponsor changed name to Bayer Pharma AG.

The sponsorship was transferred to Bayer AG, Germany, in August 2017.

Sorafenib tosylate for treatment of follicular thyroid cancer has been authorised in the EU as Nexavar since 23 May 2014.

Key facts

Active substance
Sorafenib tosylate
Medicine name
Nexavar
Disease / condition
Treatment of follicular thyroid cancer
Date of decision
13/11/2013
Outcome
Positive
Orphan decision number
EU/3/13/1999

Review of designation

During its meeting of 13 to 14 May 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designations EU/3/13/1199 and EU/3/13/1200 for Nexavar (sorafenib) as an orphan medicinal product for the treatment of follicular and papillary thyroid cancers. 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 conditions, 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 and papillary thyroid cancer. The COMP recommended that the orphan designations 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 a comparable therapeutic indication cannot be placed on the market.

Sponsor's contact details

Bayer AG
51368 Leverkusen
Germany
Tel. +49 30 300 139 003
E-mail: clinical-trials-contact@bayer.com

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.

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