EU/3/13/1127

About

On 7 June 2013, orphan designation (EU/3/13/1127) was granted by the European Commission to Pfizer Limited, United Kingdom, for inotuzumab ozogamicin for the treatment of B-cell acute lymphoblastic leukaemia.

Inotuzumab ozogamicin has been authorised in the EU as Besponsa since 29 June 2017.

The sponsorship was transferred to Pfizer Europe MA EEIG, Belgium, in July 2018.

Key facts

Active substance
inotuzumab ozogamicin
Disease / condition
Treatment of B-cell acute lymphoblastic leukaemia
Date of first decision
07/06/2013
Outcome
Positive
EU designation number
EU/3/13/1127

Review of designation

During its meeting of 10 to 12 May 2017, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/13/1127 for Besponsa (inotuzumab ozogamicin), as an orphan medicinal product for the treatment of B-cell acute lymphoblastic leukaemia (ALL). 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 B-cell ALL. The COMP recommended that the orphan designation of the medicine be maintained1.


1 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 the same therapeutic indication cannot be placed on the market.

Sponsor's contact details

Pfizer Europe MA EEIG
Boulevard de la Plaine 17
1050 Bruxelles
Belgium
Tel. +32 2554 6586
E-mail: orphan_enquiries@pfizer.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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