EU/3/11/899

About

On 27 September 2011, orphan designation (EU/3/11/899) was granted by the European Commission to Takeda Global Research and Development Centre (Europe) Ltd., United Kingdom, for 2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid (also known as ixazomib citrate) for the treatment of multiple myeloma.

In November 2013, Takeda Global Research and Development Centre (Europe) Ltd changed name to Takeda Development Centre Europe Ltd.

The sponsorship was transferred to Takeda Pharma A/S, Denmark, in March 2015.

2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid has been authorised in the EU as Ninlaro since 21 November 2016.

Key facts

Active substance
2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid
Medicine name
Ninlaro
Disease / condition
Treatment of multiple myeloma
Date of first decision
27/09/2011
Outcome
Positive
EU designation number
EU/3/11/899

Review of designation

During its meeting of 4 to 6 October 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/11/899 for Ninlaro (ixazomib1) as an orphan medicinal product for the treatment of multiple myeloma. 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 multiple myeloma. The COMP recommended that the orphan designation of the medicine be maintained2.


1Previously known as 2,2'-{2-[(1R)-1-({[(2,5-dichlorobenzoyl)amino]acetyl}amino)-3-methylbutyl]-5-oxo-1,3,2-dioxaborolane-4,4-diyl}diacetic acid.

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

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Denmark
Tel. +44 (0) 1252 842255
E-mail: regulatory.services@tmcpharma.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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