EU/3/12/1063

About

On 8 November 2012, orphan designation (EU/3/12/1063) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for panobinostat for the treatment of multiple myeloma.

Panobinostat (Farydak) has been authorised in the EU since 28 August 2015. Farydak, in combination with bortezomib and dexamethasone, is indicated for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent.

The sponsorship was transferred to Novartis Europharm Limited, Ireland in May 2018.

Key facts

Active substance
Panobinostat
Medicine name
Farydak
Disease / condition
Treatment of multiple myeloma
Date of first decision
08/11/2012
Outcome
Positive
EU designation number
EU/3/12/1063

Review of designation

During its meeting of 14 to 16 July 2015, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/12/1063 for Farydak (panobinostat) as an orphan medicinal product for the treatment of multiple myeloma (also known as plasma cell myeloma). 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 multiple myeloma. The COMP recommended that the orphan designation of the medicine be maintained1.


1The 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
Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland
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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