EU/3/05/314

About

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
Sirturo
Disease / condition
Treatment of tuberculosis
Date of first decision
26/08/2005
Outcome
Positive
EU designation number
EU/3/05/314

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.

Sponsor's contact details

Janssen-Cilag International NV
Turnhoutseweg 30
B-2340 Beerse
Belgium
Tel. +32 14 60 55 21
Fax +32 14 60 55 33

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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