On 9 December 2011, orphan designation (EU/3/11/933) was granted by the European Commission to Merrimack Pharmaceuticals UK Limited, United Kingdom, for nanoliposomal irinotecan for the treatment of pancreatic cancer.

The sponsorship was transferred to Baxter Innovations GmbH, Austria, in December 2014.

In May 2015, Baxter Innovations GmbH changed name to Baxalta Innovations GmbH.

Nanoliposomal irinotecan has been authorised in the EU as Onivyde since 14 October 2016.

For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.

Key facts

Active substance
Nanoliposomal irinotecan
Medicine name
Disease / condition
Treatment of pancreatic cancer
Date of decision
Orphan decision number

Review of designation

During its meeting of 6-8 September 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/11/933 for Onivyde (irinotecan1), as an orphan medicinal product for the treatment of pancreatic 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 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 pancreatic cancer. The COMP recommended that the orphan designation of the medicine be maintained2.

1Previously known as liposomal irinotecan.

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 the same therapeutic indication cannot be placed on the market.

Sponsor's contact details

Baxalta Innovations GmbH
Industriestrasse 67
1221 Vienna
Tel. +43 1 20 100 247 2542
Fax +43 1 20 100 247 5990

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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