EU/3/07/524: Orphan designation for the treatment of tuberculosis

(R)-2-Methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole (delamanid)

Overview

This medicine is now known as delamanid.

On 1 February 2008, orphan designation (EU/3/07/524) was granted by the European Commission to Otsuka Pharmaceutical Europe Ltd, United Kingdom, for (R)-2-Methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole for the treatment of tuberculosis.

The sponsorship was transferred to Otsuka Novel Products GmbH, Germanz, in September 2011.

(R)-2-Methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole has been authorised in the EU as Deltyba since 28 April 2014.

Key facts

Active substance
(R)-2-Methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole (delamanid)
Medicine name
Deltyba
Intended use
Treatment of tuberculosis
Orphan designation status
Positive
EU designation number
EU/3/07/524
Date of designation
02/02/2008
Sponsor
Otsuka Novel Products GmbH
Erika-Mann-Strasse 21
80636 Muenchen
Germany

Review of designation

During its meeting of 11 to 12 March 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/07/524 for Deltyba (delamanid)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 methods of treatment. As other methods of treatment for patients with tuberculosis 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 Deltyba be maintained2.


1 Previously known as (R)-2-Methyl-6-nitro-2-{4-[4-(4-trifluoromethoxyphenoxy)piperidin-1-yl]phenoxymethyl}-2,3-dihydroimidazo[2,1-b]oxazole.

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 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: Deltyba (delamanid) for the treatment of tuberculosis (PDF/82.08 KB)

    Adopted

    First published: 12/05/2014
    Last updated: 12/05/2014
    EMA/COMP/2642/2014

  • 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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