Glybera

Expired

This medicine's authorisation has expired

alipogene tiparvovec

Overview

The marketing authorisation for Glybera (alipogene tiparvovec) expired on 28 October 2017 following the decision of the marketing authorisation holder, uniQure biopharma B.V., not to apply for a renewal of the marketing authorisation. 

uniQure biopharma B.V. confirmed that it did not apply for renewal of the authorisation due to the lack of demand for this product. Glybera was granted marketing authorisation in the European Union (EU) on 25 October 2012 as a one time, single-administration gene therapy for adult patients with familial lipoprotein lipase deficiency. The marketing authorisation was valid for a 5-year period. 

The European Public Assessment Report (EPAR) for Glybera is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

This product was originally designated an orphan medicine on 8 March 2004. Glybera was withdrawn from the Community register of orphan medicinal products by the European Commission in October 2017 at the time of the withdrawal of the marketing authorisation.

Glybera : EPAR - Summary for the public

Reference Number: EMA/670094/2015

Product information

Glybera : EPAR - Product Information

Glybera : EPAR - All Authorised presentations

Glybera : EPAR - Conditions imposed on member states for safe and effective use

Product details

• Name of medicine:
  Glybera
• Active substance:
  alipogene tiparvovec
• International non-proprietary name (INN) or common name:
  alipogene tiparvovec
• Therapeutic area (MeSH):
  Hyperlipoproteinemia Type I
• Anatomical therapeutic chemical (ATC) code:
  C10AX10

Pharmacotherapeutic group

Lipid modifying agents

Therapeutic indication

Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions. The diagnosis of LPLD has to be confirmed by genetic testing. The indication is restricted to patients with detectable levels of LPL protein.

Authorisation details

• EMA product number:
  EMEA/H/C/002145
• Advanced therapy:

  This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

• Exceptional circumstances:

  This medicine was authorised under exceptional circumstances, because the applicant was unable to provide comprehensive data on the efficacy and safety of the medicine under normal conditions of use. This can happen because the condition to be treated is rare or because collection of full information is not possible or is unethical. For more information, see Pre-authorisation guidance.

• Marketing authorisation holder:
  uniQure biopharma B.V.

  Meibergdreef 61; NL-1105 BA Amsterdam; The Netherlands

• Marketing authorisation issued:
  25/10/2012
• Expiry of marketing authorisation:
  28/10/2017
• Revision:
  8

Assessment history

Changes since initial authorisation of medicine

Glybera : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Glybera : EPAR - Public assessment report

Adopted

CHMP summary of positive opinion for Glybera

AdoptedReference Number: EMA/CHMP/472167/2012

Questions and answers on the refusal of the marketing authorisation for Glybera - Outcome of re-examination

AdoptedReference Number: EMA/CHMP/474562/2011

Questions and answers on the recommendation for the refusal of the marketing authorisation for Glybera

AdoptedReference Number: EMA/CHMP/474562/2011