EU/3/15/1447

About

On 12 February 2015, orphan designation (EU/3/15/1447) was granted by the European Commission to Elli Lilly Nederland B.V., the Netherlands, for olaratumab for the treatment of soft tissue sarcoma.

Olaratumab has been authorised in the EU as Lartruvo since 9 November 2016.

Key facts

Active substance
Olaratumab
Medicine name
Lartruvo
Disease / condition
Treatment of soft tissue sarcoma
Date of decision
12/02/2015
Outcome
Positive
Orphan decision number
EU/3/15/1447

Review of designation

During its meeting of 4-6 October 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/15/1447 for Lartruvo (olaratumab) as an orphan medicinal product for the treatment of soft tissue sarcoma. 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 are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with soft tissue sarcoma. The COMP recommended that the orphan designation of the medicine be maintained1.


1The 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.

Sponsor's contact details

Eli Lilly Nederland B.V.
Papendorpseweg 83
Utrecht 3528 BJ
The Netherlands
Tel. +31 3060 25800
E-mail: eu_orphan@lilly.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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