EU/3/05/314: Orphan designation for the treatment of tuberculosis

(1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline


On 26 August 2005, orphan designation (EU/3/05/314) was granted by the European Commission to Tibotec Pharmaceuticals Ltd., Ireland, for (1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol for the treatment of tuberculosis.

The sponsorship was transferred to Tibotec BVBA, Belgium, in December 2008 and to Janssen-Cilag International N.V., Belgium, in September 2012.

(1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol has been authorised in the EU as Sirturo since 5 March 2014.

This medicine is now known as bedaquiline.

Key facts

Active substance
(1R,2S) 6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol bedaquiline
Medicine name
Intended use
Treatment of tuberculosis
Orphan designation status
EU designation number
Date of designation
Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Tel. +32 14 60 55 21
Fax +32 14 60 55 33

Review of designation

During its meeting of 7 to 9 January 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/05/314 for Sirturo (bedaquiline)1 as an orphan medicinal product for the treatment of tuberculosis. 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 satisfactory methods of treatment. As other methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained2.

1Previously known as (1R,2S)6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-(1-naphthyl)-beta-phenyl-3-quinolineethanol.
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 a comparable therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Sirturo (bedaquiline) for the treatment of tuberculosis (PDF/82.29 KB)


    First published: 14/03/2014
    Last updated: 14/03/2014

  • 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.

    EU register of orphan medicines

    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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