EU/3/17/1925

About

On 16 October 2017, orphan designation (EU/3/17/1925) was granted by the European Commission to GlaxoSmithKline Trading Services Limited, Ireland, for humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F (also known as GSK2857916) for the treatment of multiple myeloma.

The sponsor’s address was updated in April 2020. In April 2020, GlaxoSmithKline Trading Services Limited changed name to GlaxoSmithKline (Ireland) Limited.

Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F has been authorised in the EU as Blenrep since 25 August 2020.

Key facts

Active substance
Humanised monoclonal antibody targeting B-cell maturation antigen conjugated with maleimidocaproyl monomethyl auristatin F
Disease / condition
Treatment of multiple myeloma
Date of first decision
16/10/2017
Outcome
Positive
EU designation number
EU/3/17/1925

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of BLENREP at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF iconorphan medicine assessment report .

Sponsor's contact details

GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
E-mail: customercontactuk@gsk.com

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

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