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)
Table of contents
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.
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Deltyba (delamanid) for the treatment of tuberculosis (PDF/82.08 KB)
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: