EU/3/13/1115

About

This medicine is now known as ibrutinib.

On 12 March 2013, orphan designation (EU/3/13/1115) was granted by the European Commission to Janssen-Cilag International N.V., Belgium, for 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one for the treatment of mantle-cell lymphoma.

1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one for treatment of mantle cell lymphoma has been authorised in the EU as Imbruvica since 21 October 2014.

Key facts

Active substance
1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4 d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one (ibrutinib)
Medicine name
Imbruvica
Disease / condition
Treatment of mantle-cell lymphoma
Date of decision
12/03/2013
Outcome
Positive
Orphan decision number
EU/3/13/1115

Review of designation

During its meeting of 2 to 4 September 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/13/1115 for Imbruvica (ibrutinib1) as an orphan medicinal product for the treatment of mantle cell lymphoma. 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 are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with mantle cell lymphoma. The COMP recommended that the orphan designation of the medicine be maintained2.


1Previously known as 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H- pyrazolo [3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one.
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 N.V
Turnhoutseweg 30
B-2340 Beerse
Belgium
Tel. +32 146 031 89
Fax +32 146 055 33
https://www.janssen-emea.com/contactus

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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