EU/3/09/620

About

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in February 2015 on request of the sponsor.

On 3 April 2009, orphan designation (EU/3/09/620) was granted by the European Commission to Incyte Corporation Ltd, United Kingdom, for (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate for the treatment of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia.

The sponsorship was transferred to Novartis Europharm Limited, United Kingdom, in September 2010.

R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate in treatment of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia has been authorised in the EU as Jakavi since 23 August 2012.

Key facts

Active substance
(R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate
Medicine name
Jakavi
Disease / condition
Treatment of myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia
Date of decision
03/04/2009
Outcome
Withdrawn
Orphan decision number
EU/3/09/620

Review of designation

Please note that this product was withdrawn from the Community Register of designated Orphan Medicinal Products in February 2015 on request of the sponsor.

During its meeting of 10-11 May 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designations EU/3/08/572 and EU/3/09/620 for Jakavi (ruxolitinib1) as an orphan medicinal product for the treatment of chronic idiopathic myelofibrosis and myelofibrosis secondary to polycythaemia vera or essential thrombocythaemia. 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 conditions, and the existence of other satisfactory methods of treatment. As other satisfactory methods of treatment for patients with chronic idiopathic myelofibrosis 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.


1At time of orphan designation ruxolitinib was known as (R)-3-(4-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-1H-pyrazol-1-yl)-3-cyclopentylpropanenitrile phosphate.
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

Novartis Europharm Limited
Frimley Business Park
Camberley GU16 7SR
United Kingdom
Tel. +41 61 324 11 11 (Switzerland)
E-mail: orphan.enquiries@novartis.com

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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