EU/3/10/794: Orphan designation for the treatment of primary myelofibrosis

N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib)

Overview

On 1 October 2010, orphan designation (EU/3/10/794) was granted by the European Commission to Dr Ulrich Granzer, Germany, for N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate for the treatment of primary myelofibrosis.

The sponsorship was transferred to Sanofi Aventis, France, in February 2011. In October 2012, Sanofi Aventis changed name to Sanofi-Aventis Groupe.

The sponsorship was transferred to SynteractHCR Deutschland GmbH, Germany, in May 2017.

The sponsorship was transferred to Celgene Europe B.V., the Netherlands, in June 2018.

N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate for treatment of primary myelofibrosis has been authorised in the EU as Inrebic since 8 February 2021. 

This medicine is now known as fedratinib.

The sponsorship was transferred to Bristol-Myers Squibb Pharma EEIG, Ireland in September 2021.

Key facts

Active substance
N-tert-butyl-3-[(5-methyl-2-{[4-(2-pyrrolidin-1-ylethoxy)phenyl]amino}pyrimidin-4-yl)amino] benzenesulfonamide dihydrochloride monohydrate (fedratinib)
Intended use
Treatment of primary myelofibrosis
Orphan designation status
Positive
EU designation number
EU/3/10/794
Date of designation
01/10/2010
Sponsor

Bristol-Myers Squibb Pharma EEIG
Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland
Tel: +44 (0) 1423 533610
E-mail: medical.information@bms.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Inrebic at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. 

More information is available in the orphan medicine assessment report.
 

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

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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