EU/3/12/984

About

This medicine is now known as ibrutinib.

On 26 April 2012, orphan designation (EU/3/12/984) was granted by the European Commission to Nexus Oncology Ltd, United Kingdom, 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 chronic lymphocytic leukaemia.

The sponsorship was transferred to Janssen-Cilag International N.V, Belgium, in January 2013.

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 chronic lymphocytic leukaemia 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 chronic lymphocytic leukaemia
Date of decision
26/04/2012
Outcome
Positive
Orphan decision number
EU/3/12/984

Review of designation

During its meeting of 2 to 4 September 2014, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/12/984 for Imbruvica (ibrutinib1) as an orphan medicinal product for the treatment of chronic lymphocytic leukaemia (CLL). 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 CLL. 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
2340 Beerse
Belgium
Tel. +32 14 60 31 89
Fax +32 14 60 55 33
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.

How useful was this page?

Add your rating