EU/3/15/1590

About

This medicine is now known as avelumab.

On 14 December 2015, orphan designation (EU/3/15/1590) was granted by the European Commission to Merck KGaA, Germany, for recombinant human monoclonal IgG1 antibody against programmed death ligand-1 for the treatment of Merkel cell carcinoma.

The sponsorship was transferred to Merck Serono Europe Limited, United Kingdom, in August 2016.

Recombinant human monoclonal IgG1 antibody against programmed death ligand-1 has been authorised in the EU as Bavencio since 18 September 2017.

The sponsorship was transferred to Merck Europe B.V., The Netherlands, in June 2018.

Key facts

Active substance
Recombinant human monoclonal IgG1 antibody against programmed death ligand-1 (avelumab)
Medicine name
Bavencio
Disease / condition
Treatment of Merkel cell carcinoma
Date of decision
14/12/2015
Outcome
Positive
Orphan decision number
EU/3/15/1590

Review of designation

On 25 July 2017, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/15/1590 for Bavencio (avelumab1) as an orphan medicinal product for the treatment of Merkel cell 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. The COMP recommended that the orphan designation of the medicine be maintained2.


1Previously known as recombinant human monoclonal IgG1 antibody against programmed death ligand-1.

2 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 the same therapeutic indication cannot be placed on the market.

Sponsor's contact details

Merck Europe B.V.
Gustav Mahlerplein 102
lto Toren
1082 MA Amsterdam
The Netherlands
Tel. +31 2065 80548
E-mail: service@merckgroup.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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